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

This study is not yet open for participant recruitment.
Verified April 2012 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01594203
First received: April 30, 2012
Last updated: May 7, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Soft Tissue Sarcoma (STS)
 Other: F18-FGD PET/CT

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Drug Information available for: Pazopanib
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. [ Time Frame: 1 week ]
  • determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information. [ Time Frame: 4 week ]

Secondary Outcome Measures:
  • prediction of treatment efficiency [ Time Frame: 6 weeks ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Advanced Soft Tissue Sarcoma
patients with advanced Soft Tissue Sarcoma
 Other: F18-FGD PET/CT

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with advanced Soft Tissue Sarcoma prior to pazopanib therapy

Criteria

Inclusion Criteria:

  • Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment

Exclusion Criteria:

  • Other treatment
  • FDG negative tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594203

Contacts
Contact: Marina Orevi, MD marinaor@hadassah.org.il
Contact: Daniela Katz, MD DanielaKatz@hadassah.org.il

Locations
Israel
Hadassah Hebrew University Medical Center Not yet recruiting
Jerusalem, Israel
Contact: Marina Orevi, MD         marinaor@hadassah.org.il    
Contact: Daniela Katz, MD         DanielaKatz@hadassah.org.il    
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01594203     History of Changes
Other Study ID Numbers: 0103-12-HMO
Study First Received: April 30, 2012
Last Updated: May 7, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Soft Tissue Sarcoma
Pazopanib
F18-FDG PET/CT

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 23, 2013