Back to resultsLight-Scattering Spectroscopy for Detection of Breast Cancer
Primary Purpose
Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
light-scattering spectroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Healthy, no Evidence of Disease
Eligibility 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
Sites / Locations
- USC Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (light-scattering spectroscopy)
Arm Description
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.
Outcomes
Primary Outcome Measures
Accurate classifications of women with or without breast cancer
Exact binomial probabilities will be used.
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
Multivariate analyses will be used.
Secondary Outcome Measures
Full Information
NCT ID
NCT01755208
First Posted
December 18, 2012
Last Updated
November 11, 2021
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01755208
Brief Title
Light-Scattering Spectroscopy for Detection of Breast Cancer
Official Title
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
November 21, 2012 (Actual)
Primary Completion Date
November 19, 2020 (Actual)
Study Completion Date
November 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, no Evidence of Disease, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (light-scattering spectroscopy)
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
light-scattering spectroscopy
Intervention Description
Undergo light-scattering spectroscopy
Primary Outcome Measure Information:
Title
Accurate classifications of women with or without breast cancer
Description
Exact binomial probabilities will be used.
Time Frame
Up to 1 year
Title
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
Description
Multivariate analyses will be used.
Time Frame
Up to 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Van Dam
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Light-Scattering Spectroscopy for Detection of Breast Cancer
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