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


N/A
18 Years
N/A
Open (Enrolling)
Female
Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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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 CenterLos Angeles, California  90089