Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
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| First Received Date ICMJE | December 16, 2010 | ||||
| Last Updated Date | December 26, 2012 | ||||
| Start Date ICMJE | December 2010 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas [ Time Frame: up to 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01263405 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging | ||||
| Official Title ICMJE | Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging | ||||
| Brief Summary | 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 |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | primary care clinic and community sample |
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| Condition ICMJE | Sarcoma | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 83 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01263405 | ||||
| Other Study ID Numbers ICMJE | 2010-7852, Department Fund | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Montana Compton, University of California, Irvine | ||||
| Study Sponsor ICMJE | Montana Compton | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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