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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Predictive Model
* Diagnostic Test: Breast Imagers


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 200 women undergoing clinical breast MRI<br>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. | Diagnostic Test: Predictive Model<br>* 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.<br>Diagnostic Test: Breast Imagers<br>* 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.<br>|
| 50 women undergoing clinical breast MRI<br>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. | Diagnostic Test: Predictive Model<br>* 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.<br>Diagnostic Test: Breast Imagers<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the diagnostic accuracy of GRASP AB-MRI temporal kinetics in the diagnosis of breast malignancies. |  | 12 Months |