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

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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:
Information provided by (Responsible Party):
Tari King, MD, Dana-Farber Cancer Institute

Study Description
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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).

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Supine MRI Other: Neoadjuvant Therapy (NAT) Device: Ultrasound Device: Mammography Procedure: Standard of Care Device: Standard MRI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : August 2022
Actual Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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
 Device: Supine MRI
Other: Neoadjuvant Therapy (NAT)
Device: Ultrasound
Device: Mammography
Procedure: Standard of Care
Device: Standard MRI


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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..

  3. 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 Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956473


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Tari King, MD Brigham and Women's Hospital
  Study Documents (Full-Text)

Documents provided by Tari King, MD, Dana-Farber Cancer Institute:
Study Protocol and Statistical Analysis Plan  [PDF] November 8, 2022

More Information
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Responsible Party: Tari King, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02956473    
Other Study ID Numbers: 16-277
First Posted: November 6, 2016    Key Record Dates
Results First Posted: March 12, 2024
Last Update Posted: March 12, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tari King, MD, Dana-Farber Cancer Institute:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases