Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diffuse Optical Spectroscopy Imaging
Sponsored by

About this trial
This is an interventional device feasibility trial for Breast Cancer focused on measuring Breast cancer receiving chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
- Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
Exclusion Criteria:
- Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
Sites / Locations
- Beckman Laser Institute University Of California Irvine
- Chao Family Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Diagnostic Tool
Arm Description
Diffuse Optical Spectroscopy Imaging
Outcomes
Primary Outcome Measures
Diagnostic tool
Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT00540852
First Posted
October 4, 2007
Last Updated
October 28, 2022
Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Chao Family Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00540852
Brief Title
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Official Title
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 2002 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Beckman Laser Institute University of California Irvine, Chao Family Comprehensive Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Optimal management of patients with locally advanced breast cancer remains a complex therapeutic problem. Newly diagnosed breast cancers in the United States with a higher incidence in medically underserved areas. The optimal intensity and duration of neoadjuvant chemotherapy still remains controversial due to the difficulty of evaluating response to therapy. The goal would be to prevent over and under treatment of patients with neoadjuvant chemotherapy.
Detailed Description
The Researcher developed a diagnostic device called Diffuse Optical Spectroscopy Imaging is a non-invasive optical technique that utilizes intensity-modulated, near-infrared light to quantitatively measure optical properties in thick tissues.
Diffuse Optical Spectroscopy Imaging can images tissue hemoglobin , oxygen saturation, blood volume fraction, water content, fat content and cellular structure. The measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development.
There is no therapeutic benefit to the subject, especially none that might influence the indication for the diagnostic procedure as indicated. However, information obtained may lead to a new form of non-invasive imaging for the early detection of breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer receiving chemotherapy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic Tool
Arm Type
Other
Arm Description
Diffuse Optical Spectroscopy Imaging
Intervention Type
Device
Intervention Name(s)
Diffuse Optical Spectroscopy Imaging
Intervention Description
Diffuse Optical Spectroscopy Imaging
Primary Outcome Measure Information:
Title
Diagnostic tool
Description
Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female non-pregnant and age greater than or equal to 21 years old but less than 75 years old
Diagnosed with breast cancer and will be receiving neoadjuvant chemotherapy
Exclusion Criteria:
Female pregnant and age less than 21 years old and have no diagnosis of breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hsiang, M.D
Organizational Affiliation
Beckman Laser Institute University of California Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beckman Laser Institute University Of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy
We'll reach out to this number within 24 hrs