Light-Scattering Spectroscopy for Detection of Breast Cancer

This study is currently recruiting participants.

Verified January 2013 by USC/Norris Comprehensive Cancer Center

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

USC/Norris Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT01755208

First received: December 18, 2012

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 18, 2012

Last Updated Date

January 14, 2013

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01755208 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Light-Scattering Spectroscopy for Detection of Breast Cancer

Official Title ^ICMJE

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

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Healthy, no Evidence of Disease
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer

Intervention ^ICMJE

Procedure: light-scattering spectroscopy

Undergo light-scattering spectroscopy

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01755208

Other Study ID Numbers ^ICMJE

1B-12-6, NCI-2012-02769

Has Data Monitoring Committee

Yes

Responsible Party

USC/Norris Comprehensive Cancer Center

Study Sponsor ^ICMJE

USC/Norris Comprehensive Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Jacques Van Dam

USC/Norris Comprehensive Cancer Center

Information Provided By

USC/Norris Comprehensive Cancer Center

Verification Date

January 2013

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

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