Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
In this study we plan to measure bone and soft tissue sarcoma patients using Diffuse Optical
Spectroscopic Imaging to determine if analogous markers of response exist for these
patients. The first aim of this study is to measure normal volunteers using Diffuse Optical
Spectroscopic Imaging in the anatomic regions where sarcomas typically occur such as the
extremities. This will provide normal optical properties with which to compare sarcoma
measurements. The second aim of this study is to determine the feasibility of measuring
sarcoma patients with Diffuse Optical Spectroscopic Imaging. Since the optical properties
of sarcoma tissue will likely be different from breast tumor tissue, we will measure a small
cohort of patients at baseline (before treatment) to determine typical optical properties
and make any necessary instrument adjustments. The third aim of the study will involve
measuring sarcoma patients using Diffuse Optical Spectroscopic Imaging at multiple
timepoints during their treatment including at baseline, during their first week of
neoadjuvant chemotherapy, at the midpoint of therapy, and before surgical resection.
Additionally, some patients may be measured during their chemotherapy infusions as this
timepoint has shown promising preliminary data in breast cancer patients. Diffuse Optical
Spectroscopic Imaging measurements will be analyzed and compared to overall chemotherapy
response determined by pathology. Additionally, DOSI measurements will be compared to
clinical MRI (or FDG PET/CT) measurements performed at baseline and at posttreatment prior
to surgery according to RECIST/PERCIST criteria. Tumor volume reduction (or tumor metabolic
change) during chemotherapy will be compared to Diffuse Optical Spectroscopic Imaging
measurements. Finally, as a fourth study aim, biopsy specimens from patients will be
analyzed by immunohistochemistry for metabolic, proliferative, and necrotic markers. These
markers will be correlated with optical markers to help further understand the how DOSI can
inform physicians about the tumor biology of sarcomas.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas
up to 12 months
No
Bruce Tromberg, PhD
Principal Investigator
Beckman Laser Institute
United States: Institutional Review Board
2010-7852
NCT01263405
December 2010
December 2013
Name | Location |
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Beckman Laser Institute | Irvine, California 92612 |