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NCT00734838 Clinical Trial

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Breast Cancer Clinical Trial

Official title:
Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00734838
Other study ID # Pro00008003
Secondary ID NIH 5R01-CA-1005
Status Completed
Phase N/A
First received
Last updated
Start date January 2006
Est. completion date October 3, 2022

Study information
Verified date August 2023
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

Recruitment information / eligibility
Status Completed
Enrollment 213
Est. completion date October 3, 2022
Est. primary completion date October 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients having a needle biopsy of a breast mass Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• High Resolution Microendoscope
Using core biopsy and reduction mammoplasty tissue

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

Sponsors (2)
Lead Sponsor Collaborator
Duke University William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optical signatures The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast Day of procedure (less than 10 minutes)
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