The Prone to Supine Breast MRI Trial

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges (segment the tumor) so that a 3-D image of the tumor can be generated to form a BCL.

Detailed Description
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The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor. These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the breast cancer locator to help surgeons more accurately remove breast cancers.

Official Title
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The Prone to Supine Breast MRI Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Prone to Supine MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years. Female gender. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ Tumor size at least 1 cm in diameter as visualized on mammogram or US. A diagnostic breast MRI is considered to be clinically indicated. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. Exclusion Criteria: Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes. Severe claustrophobia. Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2). History of median sternotomy. Pregnancy. Patient attestation that they are not pregnant will be acceptable. Patients who have received neoadjuvant chemotherapy.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prone to Supine MRI<br>The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material. | Other: Prone to Supine MRI<br>* The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Successful Segmentation of Supine MRI Images | Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images. | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor | Compare the signal intensity with that obtained at tumor location on the prone and supine imaging. The amount of enhancement at the tumor site = segmented tumor. | 30 minutes | 
| Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary | Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging. | 30 minutes | 
| Enhancement Quantification- Tumor-to-Background Ratio | Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor. The difference between tumor and benign breast tissue is the tumor-to-background ratio | 30 minutes | 
| Time to Position and Obtain Supine Images | Calculate the additional time needed to obtain supine MRI images. After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging. The aggregate time to accomplish these tasks are noted in minutes. | 30 Minutes | 
| Overall Comfort for Prone and Supine Positions | Quantify the perceived comfort level of the prone and supine MRI as reported by participants. A single question using a Likert scale was was used. The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort. | Within 15 minutes of the scan | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer Locator