Light-Scattering Spectroscopy for Detection of Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: light-scattering spectroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (light-scattering spectroscopy)<br>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. | Procedure: light-scattering spectroscopy<br>* Undergo light-scattering spectroscopy<br>|

What is the study measuring?
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Primary Outcome Measures

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