Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

NCT03482557 | Completed Results DMC FDA Device

• 1 other identifier: 17-689
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Breast Cancer; screening; breast MRI; contrast enhanced spectral mammography

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve for Cancer Detection Rates of CESM Compared With Breast MRI for Breast Cancer Screening

  We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.

  2 years

Secondary Outcomes (2)

• Area Under the Curve for Cancer Detection Rates of CESM Compared With Abbreviated Breast MRI for Breast Cancer Screening

  2 years

• Area Under the Curve for Cancer Detection Rates of CESM Compared With Conventional 2d Mammography for Breast Cancer Screening

  2 years

Study Arms (2)

Contrast-Enhanced Spectral Mammography

EXPERIMENTAL

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.

Device: CESM

Breast MRI

EXPERIMENTAL

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.

Device: MRI

Interventions

CESM 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

Also known as: Contrast Enhanced Spectral Mammography

Contrast-Enhanced Spectral Mammography

MRI DEVICE

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

Also known as: Magnetic Resonance Imaging

Breast MRI

Eligibility Criteria

• Age: 30 Years - 110 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• GE Healthcare: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Marc Mccall
• Organization: Beth Israel Deaconess MEdical Center

mmccall1@bidmc.harvard.edu

617-418-9216

Study Officials

• Olga Brook, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Chair of Research

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 29, 2018
• Study Start: May 17, 2018
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)