UPenn
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT03664778
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.
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Notify Me18 year–82 year
Female
Observational
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 years
To detect subclinical disease not detected on mammography
Time frame: 4 years
To detect DCIS/Cancer not detected on mammography
Time frame: 4 years
Tumor size
Time frame: 4 years
Axillary nodal status
Time frame: 4 years
To determine the time of recurrence
Time frame: 4 years
Ipsilateral and contralateral breast cancer detection
University of Pennsylvania
Other
Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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