A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

Breast Cancer Clinical Trial

Official title: A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

Status Completed

Clinical Trial Summary

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.

Clinical Trial Description

The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.

Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT01372631
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Completion date: April 1, 2017