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

Sponsor
University of California, Irvine (Other)
Overall Status
Completed
CT.gov ID
NCT01263405
Collaborator
Beckman Laser Institute University of California Irvine (Other)
3
Enrollment
1
Location
46
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas Using Diffuse Optical Spectroscopic Imaging
    Study Start Date :
    Dec 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2014
    Actual Study Completion Date :
    Oct 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Normal

    normal volunteers without sarcoma
    Sarcoma

    Sarcoma

    Outcome Measures

    Primary Outcome Measures

    1. Monitoring Chemotherapy Response of Soft Tissue Sarcomas and Osteosarcomas [up to 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beckman Laser Institute Irvine California United States 92612

    Sponsors and Collaborators

    • University of California, Irvine
    • Beckman Laser Institute University of California Irvine

    Investigators

    • Principal Investigator: Bruce Tromberg, PhD, Beckman Laser Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Beckman Laser Institute and Medical Center, Bruce Tromberg, PhD., Director, Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery, University of California, Irvine
    ClinicalTrials.gov Identifier:
    NCT01263405
    Other Study ID Numbers:
    • NIH/LAMMP-2010-7852
    • Department Fund
    First Posted:
    Dec 20, 2010
    Last Update Posted:
    Feb 10, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Beckman Laser Institute and Medical Center, Bruce Tromberg, PhD., Director, Beckman Laser Institute and Medical Clinic, Professor, Departments of Biomedical Engineering and Surgery, University of California, Irvine
    Sarcoma
    Additional relevant MeSH terms:
    Sarcoma
    Osteosarcoma

    Study Results

    No Results Posted as of Feb 10, 2017