Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer
Trial ID or NCT#
NCT01970670
Status
NOT RECRUITING
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 Criteria
Ages Eligible for Study: 18 to 70
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Histologically confirmed invasive and/or in situ carcinoma of the breast2. Any race and ethnicity3. Females 18-70 years of age4. Willing and able to provide informed consent5. 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 consent2. Planned to undergo neoadjuvant chemotherapy3. Breast implants4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.)5. Breast-feeding6. Surgical excision of the biopsy proven malignancy7. Known allergy to gadolinium contrast agents8. 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
Exclusion Criteria:
- 1. Unwilling or unable to undergo informed consent2. Planned to undergo neoadjuvant chemotherapy3. Breast implants4. Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.)5. Breast-feeding6. Surgical excision of the biopsy proven malignancy7. Known allergy to gadolinium contrast agents8. 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
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Sumita Sood
650-723-0618
View on ClinicalTrials.gov
