Improving Characterization of Calcifications With Contrast-Enhanced Mammography
- Conditions
- Mammography
- Interventions
- Device: Contrast-enhanced mammographyProcedure: Biopsy
- Registration Number
- NCT03639129
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
- At least 30 years of age.
- Able to understand and willing to sign an IRB-approved written informed consent document
- GFR ≥ 30 mL/min/1.73 m2
- Pregnant
- Prior history of allergy or hypersensitivity reaction to iodinated contrast
- History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
- Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Contrast-enhanced mammography (CME) Biopsy -Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM. Contrast-enhanced mammography (CME) Contrast-enhanced mammography -Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.
- Primary Outcome Measures
Name Time Method Evaluate risk characterization of screen-detected calcifications by CEM Up to 30 days after the CEM -The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
- Secondary Outcome Measures
Name Time Method Rate of detection of additional sites of disease in the same or contralateral breast on CEM At the time of the CEM (day 1) This will be defined as presence of abnormal enhancement in the same breast at least 2 cm away from the margin of the calcifications of interest or any presence of abnormal enhancement in the contralateral breast at the time of CEM
-The reference standard in this case will also be based on pathology results from core needle biopsy (if additional biopsies are performed) or findings on surgical pathology if the patient elects for mastectomy, with the decision for core needle biopsy and lumpectomy vs mastectomy according to surgeon preference and standard of care.Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density At the time of the CEM (day 1) -Breast density category is routinely reported in the screening mammography report and accepted categories include predominantly fatty, scattered fibroglandular densities, heterogeneously dense, and extremely dense.
Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography At the time of the CEM (day 1) -Morphology of calcifications include amorphous, coarse heterogeneous, fine pleomorphic, or fine linear branching and/or based on distribution of the calcifications as either diffuse, regional, grouped, linear, or segmental, according to the descriptors in the imaging reports