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Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00540852
First Posted: October 8, 2007
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beckman Laser Institute University of California Irvine
Chao Family Comprehensive Cancer Center
Information provided by (Responsible Party):
Beckman Laser Institute and Medical Center, University of California, Irvine
  Purpose
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.

Condition Intervention
Breast Cancer Device: Diffuse Optical Spectroscopy Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Primary Purpose: Device Feasibility
Official Title: Monitoring the Response of Chemotherapy on Breast Cancer Tumor by Photon Migration Spectroscopy

Resource links provided by NLM:


Further study details as provided by Beckman Laser Institute and Medical Center, University of California, Irvine:

Primary Outcome Measures:
  • Diagnostic tool [ Time Frame: 12 weeks ]
    Diffuse Optical Spectroscopy Imaging Breast Cancer Tumor in the response of Chemotherapy


Enrollment: 77
Study Start Date: June 2002
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Diagnostic Tool
Diffuse Optical Spectroscopy Imaging
Device: Diffuse Optical Spectroscopy Imaging
Diffuse Optical Spectroscopy Imaging

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00540852


Locations
United States, California
Beckman Laser Institute University Of California Irvine
Irvine, California, United States, 92612
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute University of California Irvine
Chao Family Comprehensive Cancer Center
Investigators
Principal Investigator: David Hsiang, M.D Beckman Laser Institute University of California Irvine
  More Information

Responsible Party: Beckman Laser Institute and Medical Center, David Hsiang, M.D., Division of Surgical Oncology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00540852     History of Changes
Other Study ID Numbers: NIH-LAMMP-2002-2306
First Submitted: October 4, 2007
First Posted: October 8, 2007
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Beckman Laser Institute and Medical Center, University of California, Irvine:
Breast cancer receiving chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases