Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00734838
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2022-10-03
• Study Completion: 2022-10-03
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 213

Inclusion Criteria

• Patients having a needle biopsy of a breast mass

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Optical signatures	Day of procedure (less than 10 minutes)	The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States