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

Breast Cancer Stage II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335671
• Other study ID #: 14-476
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: January 2023

Study information

• Verified date: February 2023
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Stage I
• Breast Cancer Stage II
• Breast Neoplasms
• Early Stage Breast Cancer

Intervention

Procedure:
• Intra-operative Magnetic Resonance Imaging (MRI)

Other:
• Mass Spectrometer Analysis of Tissue Sample
Analysis of Tissue Sample

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the accuracy of MRI in detecting tumor boundaries		2 Years
Secondary	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
Secondary	To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.		2 Years
Secondary	To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion		2 Years