Abbreviated Breast MRI After Cancer Treatment

NCT03664778 | Completed DMC

• 1 other identifier: 829400
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Outcome Measures

Primary Outcomes (1)

• Invasive breast cancer detection

  To detect subclinical disease not detected on mammography

  4 years

Secondary Outcomes (5)

• DCIS and invasive cancer detection rate

  4 years

• Tumor size

  4 years

• Axillary nodal status

  4 years

• Time to recurrence

  4 years

• Ipsilateral and contralateral breast cancer detection

  4 years

Eligibility Criteria

• Age: 18 Years - 82 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Status post primary breast cancer (both invasive and DCIS) treated with breast conservation therapy at least three years prior to recruitment
• Negative DBT examination within six months prior to recruitment
• All breast densities
• Clinically asymptomatic - no palpable masses or focal thickening, etc.

You may not qualify if:

• Patients who are pregnant or lactating.
• Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6 months.
• Patients who are unwilling or unable to provide written informed consent.
• Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).
• Recent breast surgery in the past two years including breast enhancements (e.g. implants or injections) benign surgical biopsies.
• Patients who are unable to receive an MRI with Gadolinium contrast.
• Patients who have not had an MRI of the breast within the past year.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

UPenn

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Susan Weinstein, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: September 11, 2018
• Study Start: September 7, 2018
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)