An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Duke University

Status: Completed

Conditions: Breast Cancer

Treatments: Device: 49-channel optical spectrometer

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00734955

1R01EB011574-01A1 (U.S. NIH Grant/Contract)

Pro00007857

Details and patient eligibility

About

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

Enrollment: 485 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Clinical diagnosis of Breast Cancer

Exclusion Criteria:

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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485 participants in 3 patient groups

Reduction Mammoplasty

Experimental group

Description:

Patients undergoing reduction mammoplasty

Treatment:

Device: 49-channel optical spectrometer

Mastectomy

Experimental group

Description:

Patients undergoing mastectomy

Treatment:

Device: 49-channel optical spectrometer

Lumpectomy

Experimental group

Description:

Patients undergoing a lumpectomy

Treatment:

Device: 49-channel optical spectrometer