Can Contrast-Enhanced Spectral Mammography Improve the Accuracy of a Diagnosis

Terminated

• Conditions: Breast Screening
• Interventions: Diagnostic Test: Contrast-Enhanced Spectral Mammography

• Registration Number: NCT03929822
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to test whether contrast-enhanced spectral mammography (CESM) may be able to reduce the number of unnecessary biopsies in women whose screening mammograms had abnormal findings.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-04-23
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-04-29
• Status Verified: 2023-01
• Primary Completion: 2023-01-19
• Study Completion: 2023-01-19
• Last Update Submitted: 2023-01-19
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

• Women called back from a screening mammography by either FFDM or tomosynthesis with soft tissue abnormalities including masses, asymmetries, focal asymmetries or architectural distortion with or without calcifications. Patients will be questioned regarding the possibility of pregnancy and will need a negative pregnancy test prior the study intervention.

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Exclusion Criteria

• Age <30 years old
• Screening mammography with only calcifications abnormalities
• Male patients
• Pregnant or lactating patients
• Patients with any allergy to iodinated contrast
• Patients with eGFR < 45
• Patients that may be treated with radioactive iodine

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Contrast-Enhanced Spectral Mammography (CESM)	Contrast-Enhanced Spectral Mammography	Women called back from an abnormal screening mammogram/tomosynthesis exam will be offered CESM as part of their diagnostic work up. The radiologist will interpret the low energy images and record their findings.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of CESM compared to mammography	2 years	The radiologist will interpret the low energy images and record their findings.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States