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Predicting Pathological Response Within the 1st Week of Chemotherapy Using Diffuse Optical Spectroscopic Imaging

This study is currently recruiting participants.
Verified January 2013 by University of California, Irvine
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01277263
First received: January 12, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

The research study serum biomarkers for inflammatory response and correlated with DOSI measurements.

The researcher at UCI Beckman Laser Institute study the "metabolic flare" response during first week after first cycle of neoadjuvant chemotherapy in breast cancer patients. The research has learn that this flare can predict the response of chemotherapy and can predict to both an inflammatory reaction and cell death induced by cytotoxic therapy.


Condition Intervention
Breast Cancer
 Device: Diffuse Optical Spectroscopy Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predicting Pathological Response Within the 1st Week of Neoadjuvant Chemotherapy Using Functional Parameters Measured With Diffuse Optical Spectroscopic Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • improve treatment prognosis for breast cancer patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The proposed research plan has the ability to significantly impact breast cancer research and treatment


Biospecimen Retention:   Samples Without DNA

C-Protein serum


Estimated Enrollment: 37
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Diffuse Optical Spectroscopy Imaging
    Monitoring Breast Cancer during chemo therapy
Detailed Description:

Diffuse Optical Spectroscopic Imaging (DOSI) can measure predict markers of response in the first weeks of therapy.The oxyhemoglobin flare response can predictive of overall pathological response to chemotherapy in human subjects. These vascular changes can indicate the rapid transient increase and then decrease in oxyhemoglobin concentration (which is measurable with DOSI) in the first hours and days after therapeutic administration. The magnitude and time course of the flare response in patients receiving cytotoxic therapy will differ between pathological responders and non-responders. This oxyhemoglobin "flare response" can be observed In tumors where vascular dynamics are intact.

  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 and community sample

Criteria

Inclusion Criteria:

  • Female, not pregnant, not breastfeeding
  • greater than 21 years of age but less than 75 years of age
  • will be receiving neoadjuvant chemotherapy for breast cancer as prescribed by their oncologist

Exclusion Criteria:

  • Under 21 year of age
  • Female pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277263

Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu

Locations
United States, California
Beckman Laser Institute Recruiting
Irvine, California, United States, 92612
Contact: Montana Compton, RN     949-824-9265     mocomton@uci.edu    
Principal Investigator: Bruce Tromberg, PhD            
Sub-Investigator: Albert Cerussi, PhD            
Sub-Investigator: Darren Roblyer, PhD            
Sub-Investigator: John Butler, MD            
Sub-Investigator: Rita Mehta, MD            
Sub-Investigator: Phil Carpenter, MD            
Sub-Investigator: Montana Compton, RN            
Sub-Investigator: Amanda Durkin, BS            
Sponsors and Collaborators
Montana Compton
Investigators
Principal Investigator: David Hsiang, MD Beckman Laser Institute
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01277263     History of Changes
Other Study ID Numbers: DOD No. BC097812
Study First Received: January 12, 2011
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Breast Cancer

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

ClinicalTrials.gov processed this record on May 22, 2013