Short breast MRI screening trial in women at high-risk for breast cancer.

Abstract

e13049 Background: The American Cancer Society (ACS) recommends yearly breast MRI (BMRI) in addition to mammography for women with high breast cancer risk. However, standard BMRI protocols have a long acquisition time and consequently long interpretation time, which can reduce patient compliance and drive MRI cost. Therefore, we aimed to evaluate an American College of Radiology (ACR)-compliant short BMRI (SBMRI) protocol vis-à-vis compared with standard of care BMRI (SOC-BMRI) obtained in the same high-risk patient. To the best of our knowledge, a prospective study comparing both techniques does not exist. Our primary endpoint is to compare positive predictive value and cancer detection rate. Secondary endpoint is measuring and comparing patient experience between two techniques. As the study and accrual is ongoing and primary endpoint will be evaluated at the completion of accrual in a blinded fashion, here we report characteristics of patients who participated so far. Methods: This is a prospective HIPAA compliant and IRB approved trial. High risk women undergoing SOC-BMRI based on ACS screening guidelines signed an informed consent form to undergo an additional SBMRI within 7 days of the SOC-BMRI. Accrual target goal is 200 patients to give statistical power to estimate sensitivity and 95% confidence interval, with 10% or less expected to have breast cancer. Results: A total of 59 women were enrolled so far. Median age is 53 (range 26-72). Nine (15.3%) had BRCA1 or BRCA2 pathogenic mutations; 6 (10.2%) variant of uncertain significance (VUS). One (1.7%) had CDH1 pathogenic mutation, one (1.7%) had VUS in PALB2. Personal history of breast cancer was present in 2 (3.4%), atypical hyperplasia in 9 (15.3%), LCIS in 3 (5.1%), family history (FH) of breast cancer in 55 (93.2%). Hormone replacement therapy use was current in 2 (3.4%), past in 10 (16.9%). Use of raloxifene, tamoxifen, or aromatase inhibitors was current in 8 (13.6%), past in 5 (8.5%). Conclusions: In this BMRI study comparing SOC-BMRI versus SBMRI, the distribution of breast cancer risk factors reflects our routine cohort, with most patients screened based on FH of breast cancer. Clinical trial information: Primary ID 2015-0243 Secondary IDs NCI-2015-02031 Clinicaltrials.gov ID NCT02590458.