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

  • STATUS
    Recruiting
  • End date
    Jun 22, 2023
  • participants needed
    43
  • sponsor
    Dana-Farber Cancer Institute
Updated on 22 March 2022
breast-conserving surgery
mammogram
breast tumor

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.

Details
Condition Early Stage Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
Treatment Intra-operative Magnetic Resonance Imaging (MRI), Mass Spectrometer Analysis of Tissue Sample
Clinical Study IdentifierNCT02335671
SponsorDana-Farber Cancer Institute
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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