Light-Scattering Spectroscopy for Detection of Breast Cancer

University of Southern California110 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

110

Conditions

Healthy, no Evidence of Disease Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer

Interventions

light-scattering spectroscopyPROCEDURE

Undergo light-scattering spectroscopy

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Accurate classifications of women with or without breast cancer

Exact binomial probabilities will be used.

Time frame: Up to 1 year

Utility of optical markers in distinguishing cancer involved breasts from normal breasts

Multivariate analyses will be used.

Time frame: Up to 1 year

Data from ClinicalTrials.gov

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