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Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging

This study is currently recruiting participants.
Verified December 2012 by University of California, Irvine
Sponsor:
Collaborators:
American College of Radiology Imaging Network
Massachusetts General Hospital
University of Pennsylvania
Dartmouth-Hitchcock Medical Center
Brown University
University of San Francisco
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01257932
First received: December 8, 2010
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

The investigators have developed imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy, both prior to and as early as possible during the course of treatment.

The efficacy and practicality of conventional imaging approaches in the neoadjuvant chemotherapy setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging is an experimental imaging method that allows patients to be followed from baseline through treatment and surgery with a cost-effective, bedside, handheld scanning probe. The researcher evaluates a harmonized diffuse optical spectroscopic imaging technology platform that has been standardized for neoadjuvant chemotherapy monitoring. Diffuse optical spectroscopic imaging is an academic research platform that is non-invasive. Studies will be performed in five clinical sites on approximately 60 neoadjuvant chemotherapy patients.


Condition Intervention
Breast Cancer
 Device: Diffuse Optical Spectroscopy Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using 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:
  • Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
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:

The investigators are testing the effectiveness of an experimental imaging technology known as Diffuse Optical Spectroscopy Imaging in predicting the success of chemotherapy treatment (shrinkage of tumor).

Diffuse optical spectroscopic imaging measurements are made with a laser breast scanner. This bedside-capable system combines frequency-domain photon migration with steady-state tissue spectroscopy to measure complete(broadband) near-infrared absorption and reduced scattering spectra of breast tissue in vivo. DOSI measurements are made by placing the hand-held probe on the tissue surface and moving the probe to discrete locations along a grid pattern at 1.0 cm intervals. The portable high-bandwidth Frequency-Domain Photon Migration instrument employs intensity-modulated diode lasers and conventional steady-state lamps as sources and an avalanche photodiode as the detector. The time required to perform an Frequency-Domain Photon Migration measurement depends on the desired precision and number of sweeps.

  Eligibility

Ages Eligible for Study:   18 Years and older
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, 18 years of age or older, non pregnant or nursing.
  • Diagnosis of breast cancer and will be receiving chemo therapy treatments

Exclusion Criteria:

  • 18 years of age or younger, pregnant or nursing.
  • Previous treatment including chemo therapy, radiation, surgery, and hormone therapy.
  • Previous diagnosis with other form of cancer.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257932

Contacts
Contact: Montana Compton, RN 949-824-9265 mocomton@uci.edu
Contact: Erin Sullivan, BS 949-824-9265 sullivae@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    
Contact: Erin Sullivan, BS     949-824-9265     sullivae@uci.edu    
Sub-Investigator: Albert Cerussi, PhD            
Sub-Investigator: Montana Compton, RN            
Sub-Investigator: Amanda Durkin, BS            
Sub-Investigator: Darren Roblyer, PhD            
Sub-Investigator: Anais Leproux, PhD            
Sub-Investigator: Erin Sullivan, BS            
Sponsors and Collaborators
Montana Compton
American College of Radiology Imaging Network
Massachusetts General Hospital
University of Pennsylvania
Dartmouth-Hitchcock Medical Center
Brown University
University of San Francisco
Investigators
Principal Investigator: Bruce Tromberg, PhD 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: NCT01257932     History of Changes
Other Study ID Numbers: NIH/NCRR P41-RR01192, NIH/NCI
Study First Received: December 8, 2010
Last Updated: December 27, 2012
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 21, 2013