Contrast Enhanced Spectral Mammography and Magnetic Resonance Imaging in Detecting Breast Cancer
- Recommendation for breast biopsy has been made
- Recommendation for biopsy will result from an imaging work-up originating with a screening exam (mammogram, tomosynthesis, ultrasound, or MRI) that was within 3 months of biopsy
- READER STUDY INCLUSION
- CESM and MRI exam performed within 3 months of one another
- CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
- CESM studies will include at least four low energy and four recombined images (left craniocaudal [LCC], left mediolateral oblique view [LMLO], right craniocaudal [RCC], right mediolateral oblique [RMLO])
- MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted images
- Women with implants
- Participants who have a known allergy to contrast media
- Participants who have a known severe allergic response to one or more allergens, defined as anaphylaxis
- Participants with poor asthma control using the National Heart, Lung, and Blood Institute guidelines as defined by: * Symptoms > 2 days per week * Short-term beta agonist use > 2 days per week * Nighttime awakenings > 2 times per month
- Participants with Renal insufficiency or failure, as determined by glomerular filtration rate (GFR) calculation. Given that GFR is reported as a range, the majority of the reported range must be >= 60 mL/min/1.73m^2. GFR must be measured for all patients within 24 hours of the imaging exams
- Participants who are pregnant. Pregnant women are excluded from this study due to the radiation dose from the CT scan and its potential teratogenic effects on the fetus
- Participants who are breastfeeding are excluded because there is an unknown but potential risk for adverse events in nursing infants secondary to contrast administration in the mother
- Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrhythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction
- Participants with a concurrent active illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, thyroid storm
- Participants with thyroid carcinoma or thyroid disease for whom systemic radioactive iodine therapy is part of planned diagnostic work-up or treatment within 2 months following the contrast mammogram study
- Participants with non-magnetic resonance (MR) compatible objects or implants that would make MRI a contraindication
- Participants who have a pacemaker, pacer wires, implantable defibrillator, or implanted monitoring device
- Participants with intracranial clips, metal implants or external clips within 10 mm of the head
- Participants who have had a metal injury to the eye
- READER STUDY EXCLUSION
- Imaging sets with implants
- Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM
- Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2-year imaging follow-up is not available
I. To determine whether contrast enhanced spectral mammography (CESM) is non-inferior to breast magnetic resonance imaging (MRI) for breast cancer screening.
I. To determine whether CESM is non-inferior to abbreviated breast MRI for breast cancer screening.
I. To determine whether CESM is superior to mammography for breast cancer screening.
I. To determine patient preference for breast MRI versus CESM for breast cancer screening.
Prior to breast biopsy, participants undergo CESM and MRI within 3 months of each other.
After completion of study, participants are followed up for 2 years.
Trial Phase Phase NA
Trial Type Screening
Dana-Farber Harvard Cancer Center
- Primary ID 17-689
- Secondary IDs NCI-2018-00783
- Clinicaltrials.gov ID NCT03482557