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

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 Overview

• Status: Completed
• Conditions: Early Stage Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II
• Intervention / Treatment: Procedure: Intra-operative Magnetic Resonance Imaging (MRI); Other: Mass Spectrometer Analysis of Tissue Sample

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thanh Barbie, MD; Phone Number: (617) 632-3209; Email: tbarbie@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the accuracy of MRI in detecting tumor boundaries	2 Years

Secondary Outcome Measures

Outcome Measure	Time Frame
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	2 Years
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.	2 Years
To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion	2 Years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Thanh Barbie, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: January 7, 2015
• First Submitted That Met QC Criteria: January 7, 2015
• First Posted (Estimate): January 12, 2015

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Breast Conserving Surgery; Early Stage Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 14-476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No