Light-Scattering Spectroscopy for Detection of Breast Cancer

Not Applicable

Terminated

• Conditions: Healthy, no Evidence of Disease; Stage II Breast Cancer; Stage IIIC Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer

• Registration Number: NCT01755208
• Lead Sponsor: University of Southern California

Brief Summary

This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer

Detailed Description

PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.

OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.

Study Timeline

• Study Start: 2012-11-21
• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-24
• Primary Completion: 2020-11-19
• Study Completion: 2020-11-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-11
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
• Provision of informed consent prior to any study-related procedures

Exclusion Criteria

• Females with tattoos on either or both breasts
• Females with nipple piercings on either or both breasts
• Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
• Females unable to provide informed consent
• Females s/p treatment for breast cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Accurate classifications of women with or without breast cancer	Up to 1 year	Exact binomial probabilities will be used.
Utility of optical markers in distinguishing cancer involved breasts from normal breasts	Up to 1 year	Multivariate analyses will be used.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States