A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

Duke University

Status: Completed

Conditions: Breast Cancer

Treatments: Device: miniature spectral imaging system; Device: Bench-top optical spectrometer; Device: High resolution microendoscope

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01372631

Pro00028284

5R01EB011574 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing a reduction mammoplasty OR
• Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy
• Age > 18
• Clinically detectable disease either by physical examination or radiographic studies
• Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
• Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

• Patients considered in "vulnerable" populations.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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218 participants in 3 patient groups

Pressure assessment

Experimental group

Description:

30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.

Treatment:

Device: Bench-top optical spectrometer

Device: miniature spectral imaging system

Random and Systematic Errors

Experimental group

Description:

40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.

Treatment:

Device: Bench-top optical spectrometer

Device: miniature spectral imaging system

Sensitivity and Specificity Assessment

Experimental group

Description:

150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.

Treatment:

Device: High resolution microendoscope

Device: Bench-top optical spectrometer

Device: miniature spectral imaging system