Diagnostic accuracy of neuroblastoma patient imaging with [18F]mFBG PET-CT compared to [123I]mIBG scanning.
Phase 2
Completed
- Conditions
- Neuroblastoma10027655
- Registration Number
- NL-OMON49035
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
- Patients with a (clinical suspicion of) neuroblastoma who are refferred for
conventional [123I]mIBG imaging.
- age between 0-18 years old.
- written informed consent from patients and/or from parents or legal
guardians, according to local law and regulations.
Exclusion Criteria
Pregnancy of the patient
Age > 18 years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study endpoints are the number of lesions and sites of disease<br /><br>detected with 18F-mFBG PET-CT compared to the current imaging standard of care,<br /><br>123I-mIBG scan using the SIOPEN imaging scoring method for skeletal lesions and<br /><br>the total number of detected soft tissue lesions</p><br>
- Secondary Outcome Measures
Name Time Method <p>o Determine optimum imaging time of 18F-mFBG PET CT(60 min vs 120-150 min post<br /><br>injection)<br /><br>o Determine the estimation of radiation absorbed dose of 18F-mFBG<br /><br>o Adverse events of 18F-mFBG injection and PET CT s</p><br>