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

NCT02275871 | Terminated DMC

• 1 other identifier: 14-225
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of cancers and false positive findings identified on CESM versus MRI as a measure of sensitivity and specificity

  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).

  4 years

Study Arms (1)

MRI and CESM

EXPERIMENTAL

High risk patients will get standard of care screening MRI and study CESM on the same day.

Other: MRI; Other: CESM

Interventions

MRI OTHER

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

MRI and CESM

CESM OTHER

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.

Also known as: Contrast Enhanced Spectral Mammography

MRI and CESM

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• GE Healthcare: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jordana Phillips, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2014
• First Posted: October 27, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

US (1)