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

NCT01716247 | Completed

• 1 other identifier: 12-214
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Women at Increased Risk for Developing Breast Carcinoma

Keywords

Mammography (CESM); MRI; Breast screening; 12-214

Outcome Measures

Primary Outcomes (1)

• compare the sensitivity and specificity CESM

  CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.

  1 year

Study Arms (1)

pts at risk for breast cancer

EXPERIMENTAL

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.

Other: Mammography (CESM) and MRI

Interventions

Mammography (CESM) and MRI OTHER

The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.

pts at risk for breast cancer

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Study Officials

• Maxine Jochelson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

US (1)