We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Light-Scattering Spectroscopy for Detection of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01755208
Recruitment Status : Recruiting
First Posted : December 24, 2012
Last Update Posted : April 13, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
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

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Actual Study Start Date : November 21, 2012
Estimated Primary Completion Date : November 21, 2018
Estimated Study Completion Date : November 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Accurate classifications of women with or without breast cancer [ Time Frame: Up to 1 year ]
    Exact binomial probabilities will be used.

  2. Utility of optical markers in distinguishing cancer involved breasts from normal breasts [ Time Frame: Up to 1 year ]
    Multivariate analyses will be used.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755208


Contacts
Contact: Pui Yan 323-865-3000 Puiyan@med.usc.edu

Locations
United States, California
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Yan Pui    323-865-3000    Puiyan@med.usc.edu   
Principal Investigator: Jacques Van Dam         
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jacques Van Dam University of Southern California
More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01755208     History of Changes
Other Study ID Numbers: 1B-12-6
NCI-2012-02769 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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