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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00540852
First received: October 4, 2007
Last updated: June 10, 2015
Last verified: June 2015
  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: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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 University of California, Irvine:

Primary Outcome Measures:
  • Diagnostic tool [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts 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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 4, 2007
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Breast cancer receiving chemotherapy

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

ClinicalTrials.gov processed this record on July 01, 2015