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

June 18, 2018 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pts at risk for breast cancer
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
compare the sensitivity and specificity CESM
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Maxine Jochelson, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Actual)

June 19, 2018

Last Update Submitted That Met QC Criteria

June 18, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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