Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 8, 2012
April 1, 2012
6 months
April 30, 2012
May 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.
1 week
determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information.
4 week
Secondary Outcomes (1)
prediction of treatment efficiency
6 weeks
Study Arms (1)
Advanced Soft Tissue Sarcoma
patients with advanced Soft Tissue Sarcoma
Interventions
Eligibility Criteria
patients with advanced Soft Tissue Sarcoma prior to pazopanib therapy
You may qualify if:
- Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment
You may not qualify if:
- Other treatment
- FDG negative tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah Hebrew University Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2012
First Posted
May 8, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2012
Study Completion
May 1, 2013
Last Updated
May 8, 2012
Record last verified: 2012-04