Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy

Description

The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.

Study Start Date

February 2015

Estimated Completion Date

December 2021

Interventions

  • Procedure: Intra-operative Magnetic Resonance Imaging (MRI)
  • Other: Mass Spectrometer Analysis of Tissue Sample

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast
  • Physician Assistant: Hematology/Oncology

MeSH Terms

  • Breast Neoplasms
  • Early Stage Breast Cancer

Study ID

Dana-Farber Cancer Institute -- 14-476

Status

Recruiting

Trial ID

NCT02335671

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

43

Sponsor

Dana-Farber Cancer Institute

Inclusion Criteria

  • Patients must be female
  • Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
  • Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
  • Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
  • Patient must meet standard MRI guidelines and be able and willing to undergo MRI
  • Age ?18 years and < 75.
  • 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 known Li-Fraumeni or Cowden's Disease.
  • Participants with prior mantle radiation.
  • Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
  • Participants who are pregnant.
  • Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
  • Participants with known active collagen vascular disease.
  • Participants with prior history of ipsilateral breast carcinoma.
  • Patients who have biopsy confirmed multi-centric disease.
  • Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure.
  • Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (2)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Mehra Golshan MD None mgolshan@partners.org
Brigham and Womens Hospital - Boston, Massachusetts 2.4 miles Mehra Golshan MD None mgolshan@partners.org

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.