Abbreviated Breast MRI After Cancer Treatment

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03664778
• Other study ID #: 829400
• Status: Active, not recruiting
• Start date: September 7, 2018
• Est. completion date: September 30, 2024

Study information

• Verified date: February 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 82 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma, Intraductal, Noninfiltrating

Locations

Country	Name	City	State
United States	UPenn	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive breast cancer detection	To detect subclinical disease not detected on mammography	4 years
Secondary	DCIS and invasive cancer detection rate	To detect DCIS/Cancer not detected on mammography	4 years
Secondary	Tumor size	Tumor size	4 years
Secondary	Axillary nodal status	Axillary nodal status	4 years
Secondary	Time to recurrence	To determine the time of recurrence	4 years
Secondary	Ipsilateral and contralateral breast cancer detection	Ipsilateral and contralateral breast cancer detection	4 years