Back to resultsEvaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Primary Purpose
Early Stage Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intra-operative Magnetic Resonance Imaging (MRI)
Mass Spectrometer Analysis of Tissue Sample
Sponsored by
About this trial
This is an interventional diagnostic trial for Early Stage Breast Cancer focused on measuring Early Stage Breast Cancer, Breast Conserving Surgery, Breast Cancer Stage I, Breast Cancer Stage II
Eligibility 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.
Sites / Locations
- Brigham and Women's Hospital
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intra-operative Magnetic Resonance Imaging (MRI)
Arm Description
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)
Outcomes
Primary Outcome Measures
To evaluate the accuracy of MRI in detecting tumor boundaries
Secondary Outcome Measures
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
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.
To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion
Full Information
NCT ID
NCT02335671
First Posted
January 7, 2015
Last Updated
February 27, 2023
Sponsor
Dana-Farber Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT02335671
Brief Title
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Official Title
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
January 2023 (Actual)
Study Completion Date
January 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early Stage Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
Keywords
Early Stage Breast Cancer, Breast Conserving Surgery, Breast Cancer Stage I, Breast Cancer Stage II
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intra-operative Magnetic Resonance Imaging (MRI)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Intra-operative Magnetic Resonance Imaging (MRI)
Intervention Type
Other
Intervention Name(s)
Mass Spectrometer Analysis of Tissue Sample
Intervention Description
Analysis of Tissue Sample
Primary Outcome Measure Information:
Title
To evaluate the accuracy of MRI in detecting tumor boundaries
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
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
Title
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.
Time Frame
2 Years
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanh Barbie, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
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