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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
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Breast Cancer focused on measuring Breast cancer receiving chemotherapy

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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
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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

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