Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP)

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Predictive Model; Diagnostic Test: Breast Imagers

• Registration Number: NCT03927768
• Lead Sponsor: NYU Langone Health

Brief Summary

The purpose of this study is to use a magnetic resonance imaging (MRI) sequence called golden-angle radial compressed sensing and parallel imaging (GRASP) as a noninvasive and fast way to measure the wash-in contrast (dye) in the breast. MRI uses a strong magnetic field and radio waves to create images of structures in the body. The goal is to determine if benign and malignant breast lesions have different patterns of contrast wash in.

This study will ask woman planning to undergo a clinical breast MRI with contrast (dye) as part of their standard care.

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: 2018-07-31
• Study First Submitted: 2019-04-23
• Study First Submitted QC: 2019-04-23
• Study First Posted: 2019-04-25
• Primary Completion: 2023-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 264

Inclusion Criteria

• No contraindications to MRI scanning (pacemaker, implanted metallic objects, severe obesity or other condition that leads to difficulty lying in the magnet)
• Able and willing to provide informed consent

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Exclusion Criteria

• Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
200 women undergoing clinical breast MRI	Breast Imagers	At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.
200 women undergoing clinical breast MRI	Predictive Model	At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.
50 women undergoing clinical breast MRI	Predictive Model	At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.
50 women undergoing clinical breast MRI	Breast Imagers	At time of previously scheduled clinical breast MRI, 60 second postcontrast imaging sequence will be added to the clinical breast MRI. MRI will be interpreted according to usual departmental protocols.

Primary Outcome Measures

Name	Time	Method
To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies.	12 Months

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States