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

This study is currently recruiting participants.
Verified November 2012 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01716247
First received: October 25, 2012
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Women at Increased Risk for Developing Breast Carcinoma
 Other: Mammography (CESM) and MRI

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • compare the sensitivity and specificity CESM [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 within the prior 365 days (including the current day and day of mammogram).

Exclusion Criteria:

  • Women under 21.
  • Pregnant or possibly pregnant.
  • Women who have a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (i.e., allergy to either agent or 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716247

Contacts
Contact: Maxine Jochelson, MD 646-888-4507
Contact: David Dershaw, MD 646-888-4505

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Maxine Jochelson, MD     646-888-4507        
Contact: David Dershaw, MD     646-888-4505        
Principal Investigator: Maxine Jochelson, MD            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Maxine Jochelson, MD Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01716247     History of Changes
Other Study ID Numbers: 12-214
Study First Received: October 25, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Mammography (CESM)
MRI
Breast screening
12-214

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013