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NCT03927768 Clinical Trial

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

Breast Cancer Clinical Trial

Official title:
Abbreviated Breast MRI (AB-MRI) With Golden-angle Radial Compressed-sensing and Parallel Imaging (GRASP): a Short, Comprehensive Breast MRI Exam Ready for Clinical Prime Time.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03927768
Other study ID # 18-00684
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 31, 2018
Est. completion date August 31, 2025

Study information
Verified date January 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 264
Est. completion date August 31, 2025
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 99 Years
Eligibility 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 Exclusion Criteria: - Currently undergoing neoadjuvant chemotherapy for breast cancer treatment.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Predictive Model
Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort.
• Breast Imagers
Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol.

Locations
Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies. 12 Months
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