Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 5 for:    AMIGO | Brigham and Womens

Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving 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: NCT02335671
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Mehra Golshan, MD, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE January 7, 2015
First Posted Date  ICMJE January 12, 2015
Last Update Posted Date December 12, 2019
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
To evaluate the accuracy of MRI in detecting tumor boundaries [ Time Frame: 2 Years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2015)
  • To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results [ Time Frame: 2 Years ]
  • To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results. [ Time Frame: 2 Years ]
  • To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion [ Time Frame: 2 Years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Official Title  ICMJE Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Brief Summary 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.
Detailed Description

This research study is a Phase II clinical trial investigating the use of intra-operative MRI and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

Prior research has shown that intraoperative MRI and MS are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. In this study, we are evaluating the accuracy of intra-operative MRI and MS in determining whether or not all cancer tissue was removed during breast surgery.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Early Stage Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
Intervention  ICMJE
  • Procedure: Intra-operative Magnetic Resonance Imaging (MRI)
  • Other: Mass Spectrometer Analysis of Tissue Sample
    Analysis of Tissue Sample
Study Arms  ICMJE Experimental: Intra-operative Magnetic Resonance Imaging (MRI)
  • Preoperative diagnostic MRI
  • Intra-operative MRI
  • Standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated
  • Specimen to Pathology and Mass Spectrometer (Analysis of Tissue Sample)
Interventions:
  • Procedure: Intra-operative Magnetic Resonance Imaging (MRI)
  • Other: Mass Spectrometer Analysis of Tissue Sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 7, 2015)
43
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mehra Golshan, MD (617) 632-3529 MGOLSHAN@PARTNERS.ORG
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02335671
Other Study ID Numbers  ICMJE 14-476
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mehra Golshan, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mehra Golshan, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP