A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins

February 8, 2021 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

218

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Duke University Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 54706
        • University of Wisconsin - Madison

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pressure assessment
30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Experimental: Random and Systematic Errors
40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Experimental: Sensitivity and Specificity Assessment
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.
Device: miniature spectral imaging system
Use of miniature spectral imaging system
Device: Bench-top optical spectrometer
Use of bench-top optical spectrometer
Device: High resolution microendoscope
Use of high resolution microendoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Identification of the optical signatures in breast tissue
Time Frame: Day of procedure (less than 10 minutes)
Day of procedure (less than 10 minutes)

Secondary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and Specificity of the device
Time Frame: Day of procedure (less than 10 minutes)
Day of procedure (less than 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • Principal Investigator: Nimmi Ramanujam, Ph.D., Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 12, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Actual)

February 10, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00028284
  • 5R01EB011574 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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