Light-Scattering Spectroscopy for Detection of Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 29, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention
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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 110
Study Start Date: November 2012
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: light-scattering spectroscopy
Undergo light-scattering spectroscopy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755208

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Victoria Soto    323-226-6384    victoria.soto@med.usc.edu   
Principal Investigator: Jacques Van Dam         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Jacques Van Dam University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01755208     History of Changes
Other Study ID Numbers: 1B-12-6, NCI-2012-02769
Study First Received: December 18, 2012
Last Updated: April 29, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014