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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

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ClinicalTrials.gov Identifier: NCT02335671
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : November 12, 2018
Sponsor:
Information provided by (Responsible Party):
Mehra Golshan, MD, Dana-Farber Cancer Institute

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.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Procedure: Intra-operative Magnetic Resonance Imaging (MRI) Other: Mass Spectrometer Analysis of Tissue Sample Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Study Start Date : February 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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)
Procedure: Intra-operative Magnetic Resonance Imaging (MRI)
Other: Mass Spectrometer Analysis of Tissue Sample
Analysis of Tissue Sample




Primary Outcome Measures :
  1. To evaluate the accuracy of MRI in detecting tumor boundaries [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results. [ Time Frame: 2 Years ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02335671


Contacts
Contact: Mehra Golshan, MD (617) 632-3529 MGOLSHAN@PARTNERS.ORG

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mehra Golshan, MD       mgolshan@partners.org   
Principal Investigator: Mehra Golshan, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Mehra Golshan, MD       mgolshan@partners.org   
Principal Investigator: Mehra Golshan, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
Principal Investigator: Mehra Golshan, MD Dana-Farber Cancer Institute

Responsible Party: Mehra Golshan, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02335671     History of Changes
Other Study ID Numbers: 14-476
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Keywords provided by Mehra Golshan, MD, Dana-Farber Cancer Institute:
Early Stage Breast Cancer
Breast Conserving Surgery
Breast Cancer Stage I
Breast Cancer Stage II

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases