Light-Scattering Spectroscopy for Detection of Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Southern California
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01755208
First received: December 18, 2012
Last updated: October 8, 2014
Last verified: October 2014

December 18, 2012
October 8, 2014
November 2012
November 2015   (final data collection date for primary outcome measure)
  • Accurate classifications of women with or without breast cancer [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Exact binomial probabilities will be used.
  • Utility of optical markers in distinguishing cancer involved breasts from normal breasts [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Multivariate analyses will be used.
Same as current
Complete list of historical versions of study NCT01755208 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Light-Scattering Spectroscopy for Detection of Breast Cancer
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Healthy, no Evidence of Disease
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
Procedure: light-scattering spectroscopy
Undergo light-scattering spectroscopy
Experimental: Diagnostic (light-scattering spectroscopy)
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.
Intervention: Procedure: light-scattering spectroscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
November 2016
November 2015   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
United States
 
NCT01755208
1B-12-6, NCI-2012-02769
Yes
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Principal Investigator: Jacques Van Dam University of Southern California
University of Southern California
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP