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Light-Scattering Spectroscopy for Detection of Breast Cancer

Sponsor
University of Southern California (Other)
Overall Status
Terminated
CT.gov ID
NCT01755208
Collaborator
National Cancer Institute (NCI) (NIH)
110
Enrollment
1
Location
1
Arm
95.9
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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 Phase
  • Procedure: light-scattering spectroscopy
 N/A

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
Actual Enrollment :
110 participants
Allocation:
N/A
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 :
Nov 21, 2012
Actual Primary Completion Date :
Nov 19, 2020
Actual Study Completion Date :
Nov 19, 2020

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 [Up to 1 year]

    Exact binomial probabilities will be used.

  2. Utility of optical markers in distinguishing cancer involved breasts from normal breasts [Up to 1 year]

    Multivariate analyses will be used.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 USC Norris Comprehensive Cancer Center Los Angeles California United States 90033

Sponsors and Collaborators

  • University of Southern California
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jacques Van Dam, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01755208
Other Study ID Numbers:
  • 1B-12-6
  • NCI-2012-02769
First Posted:
Dec 24, 2012
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Nov 19, 2021