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

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ClinicalTrials.gov Identifier: NCT01594203
Recruitment Status : Unknown
Verified April 2012 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):

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

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort 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. [ Time Frame: 1 week ]
  2. 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 :
  1. prediction of treatment efficiency [ Time Frame: 6 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01594203     History of Changes
Other Study ID Numbers: 0103-12-HMO
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: April 2012

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