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NCT01755208 Clinical Trial

Light-Scattering Spectroscopy for Detection of Breast Cancer

Stage IIIA Breast Cancer Clinical Trial

Official title:
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01755208
Other study ID # 1B-12-6
Secondary ID NCI-2012-02769
Status Terminated
Phase N/A
First received
Last updated
Start date November 21, 2012
Est. completion date November 19, 2020

Study information
Verified date November 2021
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 110
Est. completion date November 19, 2020
Est. primary completion date November 19, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• light-scattering spectroscopy
Undergo light-scattering spectroscopy

Locations
Country Name City State
United States USC Norris Comprehensive Cancer Center Los Angeles California

Sponsors (2)
Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accurate classifications of women with or without breast cancer Exact binomial probabilities will be used. Up to 1 year
Primary Utility of optical markers in distinguishing cancer involved breasts from normal breasts Multivariate analyses will be used. Up to 1 year
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