Contrast Enhanced Spectral Mammography and Magnetic Resonance Imaging in Detecting Breast Cancer

Inclusion Criteria

• 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

Exclusion Criteria

• 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

PRIMARY OBJECTIVE:

I. To determine whether contrast enhanced spectral mammography (CESM) is non-inferior to breast magnetic resonance imaging (MRI) for breast cancer screening.

SECONDARY OBJECTIVE:

I. To determine whether CESM is non-inferior to abbreviated breast MRI for breast cancer screening.

THIRD OBJECTIVE:

I. To determine whether CESM is superior to mammography for breast cancer screening.

FOURTH OBJECTIVE:

I. To determine patient preference for breast MRI versus CESM for breast cancer screening.

OUTLINE:

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

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Jordana Phillips

• Primary ID 17-689
• Secondary IDs NCI-2018-00783
• Clinicaltrials.gov ID NCT03482557