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

• Sponsor: Hadassah Medical Organization (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01594203
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma (STS)	Other: F18-FGD PET/CT

Study Design

• Study Type: Observational
• Anticipated Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Study Start Date: May 1, 2012
• Anticipated Primary Completion Date: Nov 1, 2012
• Anticipated Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Advanced Soft Tissue Sarcoma patients with advanced Soft Tissue Sarcoma	Other: F18-FGD PET/CT

Outcome Measures

Primary Outcome Measures

1. Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. [1 week]

2. 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

1. prediction of treatment efficiency [6 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment

Exclusion Criteria:

• Other treatment

• FDG negative tumor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hadassah Hebrew University Medical Center	Jerusalem		Israel

Sponsors and Collaborators

• Hadassah Medical Organization

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hadassah Medical Organization
• ClinicalTrials.gov Identifier: NCT01594203
• Other Study ID Numbers: 0103-12-HMO
• First Posted: May 8, 2012
• Last Update Posted: May 8, 2012
• Last Verified: Apr 1, 2012

• Keywords provided by Hadassah Medical Organization: Soft Tissue Sarcoma; Pazopanib; F18-FDG PET/CT
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of May 8, 2012