Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

NCT ID: NCT03482557

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-17
• Study Completion Date: 2023-08-30

Brief Summary

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Detailed Description

Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who had both CEM and MRI evaluating a finding that initiated from a screening exam will be included. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Contrast-Enhanced Spectral Mammography

Each enrolled participant will receive a CESM either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the CESM must be performed prior to biopsy.

Group Type: EXPERIMENTAL

CESM

Intervention Type: DEVICE

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone

Breast MRI

Each enrolled participant will receive an MRI exam either at the time of screening or following screening, for a screen detected finding. If patient has a biopsy for a finding, the MRI must be performed prior to biopsy.

Group Type: EXPERIMENTAL

MRI

Intervention Type: DEVICE

MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Interventions

CESM

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone

Intervention Type: DEVICE

MRI

MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Intervention Type: DEVICE

Other Intervention Names

Contrast Enhanced Spectral Mammography; Magnetic Resonance Imaging

Eligibility Criteria

Inclusion Criteria

• CESM and MRI exam performed within 3 months of one another.
• CESM and breast MRI exams must be performed as part of imaging work-up based on a screening exam of any type (mammography, tomosynthesis, ultrasound, and MRI)
• CESM studies will include at least four low energy and four recombined images (LCC, LMLO, RCC, RMLO).
• MRI exams will include at least fluid sensitive sequence, multi-phase T1-weighted

Exclusion Criteria

• Imaging sets with implants.
• Imaging sets in which a biopsy or surgical intervention was performed since the most recent screening exam, prior to acquisition of the study MRI or CESM.
• Imaging sets in which a biopsy was recommended, but biopsy was not performed and 2 year imaging follow-up is not available

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Olga Brook

Vice-Chair of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Brook, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-689

Identifier Type: -

Identifier Source: org_study_id