Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma

• Conditions: Soft Tissue Sarcoma (STS)
• Interventions: Other: F18-FGD PET/CT

• Registration Number: NCT01594203
• Lead Sponsor: Hadassah Medical Organization

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-30
• Study Start: 2012-05
• Study First Submitted QC: 2012-05-07
• Last Update Submitted: 2012-05-07
• Study First Posted: 2012-05-08
• Last Update Posted: 2012-05-08
• Primary Completion: 2012-11
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment

Exclusion Criteria

• Other treatment
• FDG negative tumor

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Advanced Soft Tissue Sarcoma	F18-FGD PET/CT	patients with advanced Soft Tissue Sarcoma

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
prediction of treatment efficiency	6 weeks

Trial Locations

Locations (1)

Hadassah Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel