Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

Beth Israel Lahey Health

Status: Completed

Conditions: Breast Cancer

Treatments: Device: MRI; Device: CESM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03482557

17-689

Details and patient eligibility

About

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

Full 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.

Enrollment: 132 patients

Sex: Female

Ages: 30 to 110 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Contrast-Enhanced Spectral Mammography

Experimental group

Description:

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.

Treatment:

Device: CESM

Breast MRI

Experimental group

Description:

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.

Treatment:

Device: MRI