Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Women at Increased Risk for Developing Breast Carcinoma

Treatments: Other: Mammography (CESM) and MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT01716247

12-214

Details and patient eligibility

About

The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women considered at increased risk for developing breast carcinoma (those with a lifetime risk of >15%due to family history, genetic predisposition, prior radiation therapy to the chest, prior biopsy showing a high risk lesion, or personal history of breast cancer) that are being screened with breast MRI.
• Women who have a screening digital mammogram on the day of CESM or within 365 days prior

Exclusion criteria

• Women under 21.
• Pregnant or possibly pregnant.
• Women who have a contraindication to the intravenous use of iodinated - contrast agent (i.e., allergy to iodinated contrastor severely impaired renal function with a creatinine level > or = to 1.3).
• Women with breast implants.
• Women with pacemakers.
• Women with aneurysm clips that don't allow for MRI.
• Women too claustrophobic to undergo MRI.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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1,000 participants in 1 patient group

pts at risk for breast cancer

Experimental group

Description:

Women at increased risk for breast cancer who are being referred for screening MRI will be offered and consented for CESM at the same time. The 2 examinations will be performed on the same day when at all possible and if not we will make every attempt to perform CESM before MRI. Patients with outside MRI performed within 30 days and of adequate quality will also be eligible for CESM.

Treatment:

Other: Mammography (CESM) and MRI