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

• ClinicalTrials.gov Identifier: NCT02956473
• Recruitment Status: Completed
• First Posted: November 6, 2016
• Results First Posted: March 12, 2024
• Last Update Posted: March 12, 2024
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Tari King, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: November 3, 2016
• First Posted Date: November 6, 2016
• Results First Submitted Date: October 18, 2023
• Results First Posted Date: March 12, 2024
• Last Update Posted Date: March 12, 2024
• Actual Study Start Date: November 15, 2016
• Actual Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2024)

• 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

Original Primary Outcome Measures (submitted: November 3, 2016)

• Evaluate The Correlation Between Prone Breast MRI in Estimating Residual Tumor Size post-NAT and Pathologic Results, and The Correlation Between Supine Breast MRI And Pathologic Results. [ Time Frame: 2 years ]
• Compare The Correlation Between Supine Breast MRI for Estimation Of Residual Tumor Size post-NAT and The Pathologic Residual Tumor Size, and The Correlation Between Existing Breast Imaging Modalities And The Pathologic Residual Tumor Size. [ Time Frame: 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 pre-NAT and post-NAT supine MRI with prone MRI [ Time Frame: 2years ]

Current Secondary Outcome Measures (submitted: February 12, 2024)

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 [ Time Frame: after surgery ]

Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure.

Original Secondary Outcome Measures (submitted: November 3, 2016)

• 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 [ Time Frame: 2 years ]
• Assess The Perceived Benefit Of Post-Neoadjuvant Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing BCT In Our Study Patient Population [ Time Frame: 2 years ]
• Explore The Effect Of Supine MRI On Influencing BCS Outcomes [ Time Frame: 2 years ]
• Assess The Perceived Value Of Supine MRI For Adjuvant Radiation Breast Treatment Planning [ Time Frame: 2 years ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Breast Cancer

Intervention

• Device: Supine MRI
• Other: Neoadjuvant Therapy (NAT)
• Device: Ultrasound
• Device: Mammography
• Procedure: Standard of Care
• Device: Standard MRI

Study Arms

Experimental: Supine MRI

• 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

Interventions:

• Device: Supine MRI
• Other: Neoadjuvant Therapy (NAT)
• Device: Ultrasound
• Device: Mammography
• Procedure: Standard of Care
• Device: Standard MRI

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2022): 57
• Original Estimated Enrollment (submitted: November 3, 2016): 74
• Actual Study Completion Date: August 2022
• Actual Primary Completion Date: August 2022 (Final data collection date for primary outcome measure)

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
• 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02956473
• Other Study ID Numbers: 16-277
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tari King, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Mehra Golshan, MD, Dana-Farber Cancer Institute
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tari King, MD; Brigham and Women's Hospital

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: February 2024