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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01594203
Other study ID # 0103-12-HMO
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 30, 2012
Last updated May 7, 2012
Start date May 2012
Est. completion date May 2013

Study information

Verified date April 2012
Source Hadassah Medical Organization
Contact Marina Orevi, MD
Email marinaor@hadassah.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date May 2013
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment

Exclusion Criteria:

- Other treatment

- FDG negative tumor

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
F18-FGD PET/CT


Locations

Country Name City State
Israel Hadassah Hebrew University Medical Center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. 1 week
Primary determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information. 4 week
Secondary prediction of treatment efficiency 6 weeks