11C-MET PET(/CT) vs 18F-FDG PET(/CT) in the follow-up of differentiated thyroid cancer*
Completed
- Conditions
- differentiated thyroid carcinoma10043739
- Registration Number
- NL-OMON32909
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
Study 1
- > 18 years old
- Total thyroidectomy
- Negative post-treatment 131I-WBS with elevated Tg(on) (>5.0 ng/ml)
- Signed informed consent ;Study 2
- > 18 years old
- Total thyroidectomy
- Patients with persistent or recurrent Hürthlecell carcinoma in post-ablation phase or during follow-up
- Signed informed consent
Exclusion Criteria
Both studies:
- Pregnancy
- Patients with any signs of neurological or psychiatric disorders that will preclude him/her from expressing her/his own free will
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A qualitative and semi-quantitative (standardized uptake values (SUVs)) reading<br /><br>of all the PET studies will be performed. Comparison with data derived from<br /><br>clinical CT imaging data, and where feasible histological or cytological<br /><br>confirmation, will take place.<br /><br><br /><br>Ojective/Study 1: the results of 11C-MET PET will be compared with the clinical<br /><br>FDG PET<br /><br><br /><br>Objective/Study 2: the results of 11C-MET PET will be compared with the<br /><br>clinical FDG PET<br /><br>The results of both PET scan will also be compared with the (diagnostic and)<br /><br>post-treatment 131I-WBS.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Premature termination of the study will be only if interim analysis after 15<br /><br>and 10 evaluable scans for study/objective 1 and study/objective 2,<br /><br>respectively, showed negative or undoubtedly results for the 11C-MET PET<br /><br>compared to the clinical FDG PET.</p><br>