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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02275871
Recruitment Status : Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : February 15, 2019
GE Healthcare
Information provided by (Responsible Party):
Jordana Phillips, MD, Beth Israel Deaconess Medical Center

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

Condition or disease Intervention/treatment Phase
Breast Cancer Other: MRI Other: CESM Not Applicable

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 screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI
Study Start Date : November 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MRI and CESM
High risk patients will get standard of care screening MRI and study CESM on the same day.
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.
Other Name: Contrast Enhanced Spectral Mammography

Primary Outcome Measures :
  1. Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity [ Time Frame: 4 years ]
    All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02275871

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
GE Healthcare
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Principal Investigator: Jordana Phillips, MD Beth Israel Deaconess Medical Center

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Responsible Party: Jordana Phillips, MD, Principal Investigator, Beth Israel Deaconess Medical Center Identifier: NCT02275871     History of Changes
Other Study ID Numbers: 14-225
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Keywords provided by Jordana Phillips, MD, Beth Israel Deaconess Medical Center:
Breast Cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases