Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Study Overview
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Brief Summary
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This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).

Detailed Description
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The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy. The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately

Official Title
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Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Supine MRI
* Other: Neoadjuvant Therapy (NAT)
* Device: Ultrasound
* Device: Mammography
* Procedure: Standard of Care
* Device: Standard MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be female Participants must have a pre-operative standard mammogram with or without ultrasound. Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH) Patient must meet standard MRI guidelines and be able and willing to undergo MRI Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively). Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Participants with a known BRCA 1 or 2 mutation. Participants with a known Li-Fraumeni or Cowden's Disease. Participants with prior mantle radiation. Participants with inflammatory breast cancer or multi-centric disease Participants who are pregnant. Participants who are already enrolled in a conflicting investigational trial Participants with known active collagen vascular disease. Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy. Patients who have biopsy confirmed multi-centric disease. Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supine MRI<br>Standard MRI will be performed Supine MRI will be performed Participant will receive mammography and ultrasound Breast Radiologist will take a brief survey. Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care Standard of care will be performed | Device: Supine MRI<br> <br> Other: Neoadjuvant Therapy (NAT)<br> <br> Device: Ultrasound<br> <br> Device: Mammography<br> <br> Procedure: Standard of Care<br> <br> Device: Standard MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate The Correlation Between Prone Breast MRI in Estimating Tumor Size at upfront surgery or post-NAT and Pathologic Results, and The Correlation Between Supine Breast MRI And Pathologic Results. |  | 2 years | 
| Compare The Correlation Between Supine Breast MRI for Estimation Of Tumor Size at upfront surgery or post-NAT and The Pathologic Residual Tumor Size, and The Correlation Between Existing Breast Imaging Modalities And The Pathologic Residual Tumor Size. |  | 2 Years | 
| Characterize The Changes Occurring In Breast Tumor-Associated Properties/ Dimensions Between The Prone And Supine Imaging Position And To Determine The Correlation Of Tumor Location And Geometry On supine MRI with prone MRI |  | 2years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess The Value Of Supine MRI For Radiologists Performing Second Look US Examinations/ Biopsies Following Identification Of New Lesions on MRI, And Performing Preoperative Lesion Localization Using Supine MRI Guidance |  | 2 years | 
| Assess The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population |  | 2 years | 
| Explore The Effect Of Supine MRI On Influencing Breast-conserving Surgery (BCS) Outcomes |  | 2 years | 
| Assess The Perceived Value Of Supine MRI For Adjuvant Radiation Breast Treatment Planning |  | 2 years | 

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