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Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

NCT02275871 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-03-16

No results posted yet for this study

Summary

This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

Conditions

Interventions

OTHER

MRI

High risk screening MRI will be performed as part of the patient's routine care.

OTHER

CESM

After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.

Sponsors & Collaborators

Principal Investigators

  • Jordana Phillips, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02275871 on ClinicalTrials.gov