Soft Tissue Sarcoma (STS)NCT01594203
Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma (STS), run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma (STS)
- What is being tested?
- F18-FGD PET/CT
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with advanced Soft Tissue Sarcoma prior to pazopanib therapy
Who may be able to join
- Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment
Who cannot join
- Other treatment
- FDG negative tumor
Trial locations and contacts
1 site in 1 country.
Marina Orevi, MD contact
Daniela Katz, MD contact
Israel1 site
Hadassah Hebrew University Medical Center
Jerusalem
Marina Orevi, MD, marinaor@hadassah.org.il
Daniela Katz, MD, DanielaKatz@hadassah.org.il
About this study
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.
Read more
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.
- Conditions
- Soft Tissue Sarcoma (STS)
- Being tested
- F18-FGD PET/CT
- Keywords
- Soft Tissue Sarcoma, Pazopanib, F18-FDG PET/CT
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F18-FGD PET/CTOther
| Study group | Role | What they receive |
|---|---|---|
| Advanced Soft Tissue Sarcoma | patients with advanced Soft Tissue Sarcoma Receives: Other: F18-FGD PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment.
Measured: 1 week
determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information.
Measured: 4 week
Secondary outcomes (1)
prediction of treatment efficiency
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2012 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594203
- Sponsor's protocol ID
- 0103-12-HMO
- Status last verified
- Apr 2012
- First submitted
- 30 Apr 2012
- Last updated
- 8 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma
- ClinicalTrials.gov ID
- NCT01594203
- Acronym / sponsor ID
- 0103-12-HMO
- Conditions
- Soft Tissue Sarcoma (STS)
- Keywords
- Soft Tissue Sarcoma, Pazopanib, F18-FDG PET/CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 8 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Soft Tissue Sarcoma | – | Other: F18-FGD PET/CTpatients with advanced Soft Tissue Sarcoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced Soft Tissue Sarcoma prior to pazopanib therapy
Key inclusion criteria (1 listed)
- Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment
Key exclusion criteria (2 listed)
- Other treatment
- FDG negative tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F18-FGD PET/CT | Other | Advanced Soft Tissue Sarcoma |
Primary outcome
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
1 secondary outcome
prediction of treatment efficiency
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Orevi, MD contact
Daniela Katz, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Soft Tissue Sarcoma (STS), run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Orevi, MD (marinaor@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.