Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging|
- Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Device: Diffuse Optical Spectroscopy Imaging
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257932
|United States, California|
|Beckman Laser Institute|
|Irvine, California, United States, 92612|
|Principal Investigator:||Bruce Tromberg, PhD||Beckman Laser Institute|