NCT02335671

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Intra-operative Magnetic Resonance Imaging (MRI)
OTHER	Mass Spectrometer Analysis of Tissue Sample	Analysis of Tissue Sample

Timeline

• Start date: 2015-02-01
• Primary completion: 2023-01-01
• Completion: 2023-01-01
• First posted: 2015-01-12
• Last updated: 2023-02-28

Locations

2 sites across 1 country: United States