Status:

TERMINATED

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

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

GE Healthcare

Conditions:

Breast Cancer

Eligibility:

FEMALE

30+ years

Phase:

NA

Brief Summary

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

Detailed Description

This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer. Standard...

Eligibility Criteria

Inclusion

  • Women
  • Age \> or equal to 30 years
  • High risk (\>20% lifetime risk)
  • Has a bilateral mammogram within the last 7 months
  • Has had a same day high risk screening MRI

Exclusion

  • Participants who have a known allergy or contraindication to iodinated contrast.
  • Participants who have a known allergy to food or medications.
  • Participants who have renal insufficiency or failure.
  • Participants who are pregnant or breastfeeding.
  • Participants with a concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.

Key Trial Info

Start Date :

November 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2020

Estimated Enrollment :

44 Patients enrolled

Trial Details

Trial ID

NCT02275871

Start Date

November 1 2014

End Date

January 1 2020

Last Update

March 16 2020

Active Locations (1)

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215