- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594203
Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma
Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in 60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel therapy in advanced cases survival is still short, approximately 12 month.
Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced pretreated STS.
Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for pre- / post- treatment evaluation or follow up.
Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources.
The aim of the study is to investigate the contribution of FDG PET/CT to assessment of treatment response.
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Marina Orevi, MD
- Email: marinaor@hadassah.org.il
Study Contact Backup
- Name: Daniela Katz, MD
- Email: DanielaKatz@hadassah.org.il
Study Locations
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Jerusalem, Israel
- Hadassah Hebrew University Medical Center
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Contact:
- Marina Orevi, MD
- Email: marinaor@hadassah.org.il
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Contact:
- Daniela Katz, MD
- Email: DanielaKatz@hadassah.org.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment
Exclusion Criteria:
- Other treatment
- FDG negative tumor
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Advanced Soft Tissue Sarcoma
patients with advanced Soft Tissue Sarcoma
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.
Time Frame: 1 week
|
1 week
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determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information.
Time Frame: 4 week
|
4 week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
prediction of treatment efficiency
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0103-12-HMO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Soft Tissue Sarcoma (STS)
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Washington University School of MedicinePolaris GroupRecruitingSoft Tissue Sarcoma | Sarcoma,Soft Tissue | StsUnited States
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
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University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States
-
National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
-
CytRxUnknownUnresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States, Australia, Russian Federation, Hungary, India, Romania, Ukraine
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National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
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Centre Leon BerardNovartis; National Cancer Institute, FranceRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
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UNICANCERRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
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University of Colorado, DenverAgenus Inc.RecruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue SarcomaUnited States
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-
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