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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734955
• Other study ID #: Pro00007857
• Secondary ID: 1R01EB011574-01A
• Status: Completed
• Phase: N/A
• Start date: May 2006
• Est. completion date: July 2017

Study information

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

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 485
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Breast Cancer

Exclusion Criteria:

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 49-channel optical spectrometer

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of the optical signatures of breast tissue.	The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.	Day of procedure