Abbreviated Breast MRI After Cancer Treatment

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • UPenn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women who have had primary breast cancer treated with breast conservation therapy and who fit the inclusion criteria listed below.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive breast cancer detection	To detect subclinical disease not detected on mammography	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DCIS and invasive cancer detection rate	To detect DCIS/Cancer not detected on mammography	4 years
Tumor size	Tumor size	4 years
Axillary nodal status	Axillary nodal status	4 years
Time to recurrence	To determine the time of recurrence	4 years
Ipsilateral and contralateral breast cancer detection	Ipsilateral and contralateral breast cancer detection	4 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Susan Weinstein, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2018
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 11, 2018

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Breast Diseases; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Carcinoma In Situ; Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating
• Other Study ID Numbers: 829400

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No