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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372631
• Other study ID #: Pro00028284
• Secondary ID: 5R01EB011574
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: April 1, 2017

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• miniature spectral imaging system
Use of miniature spectral imaging system
• Bench-top optical spectrometer
Use of bench-top optical spectrometer
• High resolution microendoscope
Use of high resolution microendoscope

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Wisconsin - Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute for Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the optical signatures in breast tissue		Day of procedure (less than 10 minutes)
Secondary	Sensitivity and Specificity of the device		Day of procedure (less than 10 minutes)