Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT01263405
First received: December 16, 2010
Last updated: December 26, 2012
Last verified: December 2012

December 16, 2010
December 26, 2012
December 2010
December 2013   (final data collection date for primary outcome measure)
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01263405 on ClinicalTrials.gov Archive Site
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Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging

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

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
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Non-Probability Sample

primary care clinic and community sample

Sarcoma
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  • Normal
    normal volunteers without sarcoma
  • Sarcoma
    Sarcoma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
83
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263405
2010-7852, Department Fund
Yes
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: Bruce Tromberg, PhD Beckman Laser Institute
University of California, Irvine
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP