Auto-populated list of related Clinical Trials
(Breast, Cleft Lip and Palate, Hand, Lymphedema, Oral, Skin, Trauma)

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting

Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer

The primary objective is to determine how accurately one can estimate the size of the index tumor on preoperative imaging in patients with known breast cancer, using pathology as a reference standard. The primary endpoint, which will be measured on CEDM,and CE-MRI, is the maximum diameter (mm) of the index tumor.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Eligibility


Identify inclusion criteria

   1. Histologically confirmed invasive and/or in situ carcinoma of the breast

   2. Any race and ethnicity

   3. Females 18-70 years of age

   4. Willing and able to provide informed consent

   5. Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a
   CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment
   or procedure between the CEDM and CE-MRI

Identify exclusion criteria

   1. Unwilling or unable to undergo informed consent

   2. Planned to undergo neoadjuvant chemotherapy

   3. Breast implants

   4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be
   performed for confirmation.)

   5. Breast-feeding

   6. Surgical excision of the biopsy proven malignancy

   7. Known allergy to gadolinium contrast agents

   8. Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other
   ferromagnetic surgical implant or severe claustrophobia)

   9. Suspected to be at risk to complications from the contrast agent. These include the
   standard iodinated contrast agent contraindications:

      1. Subject has renal insufficiency as determined by an elevated serum creatinine and
      is not being treated with dialysis.

      2. Documentation of a normal eGFR (MDRD) within the previous 2 months will be
      required for any subject with any of the following risk factors for renal
      insufficiency:

   i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of
   renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other
   medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c.
   Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has
   had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or
   severe asthma regularly treated with medication f. Subject has had an episode of
   serious allergic reaction (anaphylaxis) to any substance

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sumita Sood
650-723-0618
Recruiting