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Supine MRI in Breast Cancer Patients Receiving Neoadjuvant Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02956473
Recruitment Status : Recruiting
First Posted : November 6, 2016
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mehra Golshan, MD, Dana-Farber Cancer Institute

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 treatment 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 Device: Ultrasound Device: Mammography Procedure: Standard of Care 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 the treatment of women with breast cancer before and after receiving neoadjuvant therapy.

The purpose of this study is to assess the value of supine breast MRI as a new imaging method for women receiving neoadjuvant therapy. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Supine MRI in Breast Cancer Patients Receiving Neoadjuvant Therapy
Actual Study Start Date : November 15, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.
  • All new patients will receive Neoadjuvant Therapy via standard of care
  • Standard of care will be performed
Device: Supine MRI
Other: Neoadjuvant Therapy
Device: Ultrasound
Device: Mammography
Procedure: Standard of Care



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Explore The Effect Of Supine MRI On Influencing BCS Outcomes [ Time Frame: 2 years ]
  4. Assess The Perceived Value Of Supine MRI For Adjuvant Radiation Breast Treatment Planning [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (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 neoadjuvant therapy (NAT) upfront
  • 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 and <70 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.

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


Contacts
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Contact: Mehra Golshan, MD 617-632-2174 mgolshan@partners.org

Locations
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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mehra Golshan, MD    617-632-2174    mgolshan@partners.org   
Principal Investigator: Mehra Golshan, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mehara Golshan, MD    617-632-2174    mgolshan@partners.org   
Principal Investigator: Mehra Golshan, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Mehra Golshan, MD Brigham and Women's Hospital
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Responsible Party: Mehra Golshan, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02956473    
Other Study ID Numbers: 16-277
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mehra Golshan, 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