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A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Device: miniature spectral imaging system
Device: Bench-top optical spectrometer
Device: High resolution microendoscope
Registration Number
NCT01372631
Lead Sponsor
Duke University
Brief 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.

Detailed 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
218
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.
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Exclusion Criteria
  • Patients considered in "vulnerable" populations.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Random and Systematic Errorsminiature spectral imaging system40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
Pressure assessmentminiature spectral imaging system30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
Sensitivity and Specificity Assessmentminiature spectral imaging system150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.
Sensitivity and Specificity AssessmentBench-top optical spectrometer150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.
Pressure assessmentBench-top optical spectrometer30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
Random and Systematic ErrorsBench-top optical spectrometer40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
Sensitivity and Specificity AssessmentHigh resolution microendoscope150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system.
Primary Outcome Measures
NameTimeMethod
Identification of the optical signatures in breast tissueDay of procedure (less than 10 minutes)
Secondary Outcome Measures
NameTimeMethod
Sensitivity and Specificity of the deviceDay of procedure (less than 10 minutes)

Trial Locations

Locations (2)

University of Wisconsin - Madison

🇺🇸

Madison, Wisconsin, United States

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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