Trial Information
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Accurate classifications of women with or without breast cancer
Outcome Description:
Exact binomial probabilities will be used.
Outcome Time Frame:
Up to 1 year
Safety Issue:
No
Principal Investigator
Jacques Van Dam
Investigator Role:
Principal Investigator
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
1B-12-6
NCT ID:
NCT01755208
Start Date:
November 2012
Completion Date:
November 2014
Related Keywords:
- Healthy, no Evidence of Disease
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Breast Neoplasms
Name | Location |
USC Norris Comprehensive Cancer Center |
Los Angeles, California 90089 |