Light-Scattering Spectroscopy for Detection of Breast Cancer

NCT01755208 | Terminated DMC

• 2 other identifiers: 1B-12-6NCI-2012-02769
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Accurate classifications of women with or without breast cancer

  Exact binomial probabilities will be used.

  Up to 1 year

• Utility of optical markers in distinguishing cancer involved breasts from normal breasts

  Multivariate analyses will be used.

  Up to 1 year

Study Arms (1)

Diagnostic (light-scattering spectroscopy)

EXPERIMENTAL

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

Interventions

light-scattering spectroscopy PROCEDURE

Undergo light-scattering spectroscopy

Diagnostic (light-scattering spectroscopy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jacques Van Dam

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: November 21, 2012
• Primary Completion: November 19, 2020
• Study Completion: November 19, 2020
• Last Updated: November 19, 2021

Record last verified: 2021-11

Locations

US (1)