Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 57
- Locations
- 2
- Primary Endpoint
- Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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
Investigators
Tari King, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
Outcomes
Primary Outcomes
Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
Time Frame: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.
Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size
Time Frame: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..
Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.
Time Frame: at time of MRI imaging
Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images
Secondary Outcomes
- 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(after surgery)