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Spots Global Cancer Trial Database for Abbreviated Breast MRI After Cancer Treatment

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Trial Identification

Brief Title: Abbreviated Breast MRI After Cancer Treatment

Official Title: Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)

Study ID: NCT03664778

Interventions

Study Description

Brief Summary: 500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.

Detailed Description: Women treated for primary breast cancer who undergo breast conservation therapy face an increased risk of developing a second breast cancer in the ipsilateral and the contralateral breast. Although mammographic screening is recommended annually, the sensitivity of mammography is limited in these patients due to the post treatment changes from previous surgery and radiation. We propose supplemental screening with an abbreviated form of breast MRI ("fast MRI") examination in addition to mammographic screening, in order to study whether we can detect subclinical disease that may not be detected on mammography or on physical examination. Several tumor characteristics correlate with overall survival such as the extent of local recurrence and the size of the local recurrence, with larger extent and increased size of local recurrence correlating with adverse survival. In addition, the shorter time interval to the ipsilateral breast cancer recurrence from completion of treatment, is associated with increased risk of developing distant metastasis and breast cancer mortality. We will assess additional cancer detection with fast MRI after negative mammography in the ipsilateral as well as the contralateral breast. The goal of the supplemental screening with fast breast MRI would be to detectsubclinical disease not detected on mammography and thus improve patient outcomes.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

UPenn, Philadelphia, Pennsylvania, United States

Contact Details

Name: Susan Weinstein, MD

Affiliation: University of Pennsylvania

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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