Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy, no Evidence of Disease
- Sponsor
- University of Southern California
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Accurate classifications of women with or without breast cancer
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Accurate classifications of women with or without breast cancer
Time Frame: Up to 1 year
Exact binomial probabilities will be used.
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
Time Frame: Up to 1 year
Multivariate analyses will be used.