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Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer
Not Recruiting
Trial ID: NCT01970670
Purpose
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.
Official Title
Contrast-Enhanced Digital Mammography (CEDM) vs Contrast-Enhanced Breast MRI (CE-MRI) in Patients With Known Breast Cancer
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
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sumita Sood
650-723-0618