Light-Scattering Spectroscopy for Detection of Breast Cancer

University of Southern California

Status: Terminated

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

Treatments: Procedure: light-scattering spectroscopy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01755208

1B-12-6

NCI-2012-02769 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Diagnostic (light-scattering spectroscopy)

Experimental group

Description:

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.

Treatment:

Procedure: light-scattering spectroscopy