Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2010 |
| End Date: | October 2014 |
The purpose of this study is to determine the ability of a specific imaging method, termed
Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which
can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in
patients with sarcomas. Sarcoma patients face comparatively poor response rates to
chemotherapy and early, non-invasive indications of response could provide physicians with
the information necessary to make evidence-based changes in treatment strategies. Patients
who do not demonstrate early signs of response would be spared the unnecessary side-effects
of an ineffective chemotherapy regimen, and could either be switched to a different regimen
or undergo surgery
Diffuse Optical Spectroscopic Imaging, to provide metabolic and functional information which
can be used to predict overall response to preoperative (neoadjuvant) chemotherapy in
patients with sarcomas. Sarcoma patients face comparatively poor response rates to
chemotherapy and early, non-invasive indications of response could provide physicians with
the information necessary to make evidence-based changes in treatment strategies. Patients
who do not demonstrate early signs of response would be spared the unnecessary side-effects
of an ineffective chemotherapy regimen, and could either be switched to a different regimen
or undergo surgery
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.
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.
Inclusion Criteria:
- Any subjects with no current or previous history of sarcoma are eligible to be a
normal volunteer
- Any subject with a sarcoma neoplasm is eligible to be measured for aim 2 of the study
- Only patients undergoing neoadjuvant chemotherapy for sarcoma are eligible for Aim 3
of the study
Exclusion Criteria:
- Age less that 18 year old
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