Abbreviated Breast MRI After BCT



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 82
Updated:9/13/2018
Start Date:September 7, 2018
End Date:September 2022
Contact:Alexa Edenburg, B.S.
Email:alexa.edenburg@uphs.upenn.edu
Phone:2157467050

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

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.

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.

Inclusion Criteria:

1. Status post primary breast cancer (both invasive and DCIS) treated with breast
conservation therapy at least three years prior to recruitment

2. Negative DBT examination within six months prior to recruitment

3. All breast densities

4. Clinically asymptomatic - no palpable masses or focal thickening, etc.

Exclusion Criteria:

1. Patients who are pregnant or lactating.

2. Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6
months.

3. Patients who are unwilling or unable to provide written informed consent.

4. Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).

5. Recent breast surgery in the past two years including breast enhancements (e.g.
implants or injections) benign surgical biopsies.

6. Patients who are unable to receive an MRI with Gadolinium contrast.

7. Patients who have not had an MRI of the breast within the past year.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
Phone: 215-746-7050
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Philadelphia, PA
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