- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01755208
Light-Scattering Spectroscopy for Detection of Breast Cancer
Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- USC Norris Comprehensive Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Undergo light-scattering spectroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accurate classifications of women with or without breast cancer
Time Frame: Up to 1 year
|
Exact binomial probabilities will be used.
|
Up to 1 year
|
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
Time Frame: Up to 1 year
|
Multivariate analyses will be used.
|
Up to 1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jacques Van Dam, University of Southern California
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1B-12-6
- NCI-2012-02769 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stage II Breast Cancer
-
University of Colorado, DenverActive, not recruitingStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Ohio State University Comprehensive Cancer CenterCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Stage III Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of ArizonaNational Cancer Institute (NCI)CompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast CancerUnited States
-
Robert H. Lurie Cancer CenterNational Cancer Institute (NCI)WithdrawnStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedStage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
National Cancer Institute (NCI)CompletedStage I Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
-
Memorial Sloan Kettering Cancer CenterActive, not recruitingGynecologic Cancer | Stage I Breast Cancer | Stage II Breast Cancer | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage III Breast Cancer | Stage III Gynecologic Cancer | Stage III Colorectal Cancer | Stage I Colorectal Cancer | Stage II Colorectal Cancer | Stage I Gynecologic... and other conditionsUnited States
-
City of Hope Medical CenterTerminatedStage I Breast Cancer | Cancer Survivor | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
Clinical Trials on light-scattering spectroscopy
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedCervical Cancer | Precancerous ConditionUnited States, Canada
-
British Columbia Cancer AgencyNational Cancer Institute (NCI)CompletedCervical Cancer | Precancerous Condition
-
Vanderbilt UniversityNational Cancer Institute (NCI)CompletedBreast CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)Completed
-
University of California, IrvineBeckman Laser Institute University of California IrvineCompletedOther Lesions of Oral MucosaUnited States
-
British Columbia Cancer AgencyNational Cancer Institute (NCI)CompletedCervical Cancer | Precancerous ConditionCanada
-
National Eye Institute (NEI)Completed
-
Shanghai Jiao Tong University School of MedicineShanghai Photonic View Technology Co., Ltd.Not yet recruitingDiabetes Mellitus | Medical Device
-
Shanghai Jiao Tong University School of MedicineShanghai Photonic View Technology Co., Ltd.Not yet recruitingType 2 Diabetes | Medical DeviceChina
-
University Hospital, Basel, SwitzerlandCompleted