68Ga-SATO in paediatric neuroblastoma patient; exploratory, safety, non-randomized, open label, comparative study - GAP NBL study*

Phase 2

Recruiting

Conditions: neuroblastoma
10027656

Registration Number: NL-OMON51360

Lead Sponsor: Prinses Máxima Centrum voor Kinderoncologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age 0-18 years
- Written informed consent (by legal representative) and assent consent from
the patient when applicable
- Patients with a clinical suspicion of neuroblastoma who are referred for the
first time for conventional M123IBG imaging and patients with known NBL who are
referred for for follow-up M123IBG imaging

Exclusion Criteria

- Children with pre-existing severe auto-immune diseases.
- Use of therapeutic long-acting somatostatin analogs (e.g. Sandostatin®,
Lanreotide®) within the 21 days before the planned infusion of 68Ga-SATO.
- Use of diuretics within 24 hours before the planned infusion of 68Ga-SATO.
- pregnancy of the patient

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the short term safety and tolerability of 68Ga-SATO, according to<br /><br>CTCAE v5.0.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Absolute number of detected lesions and lesion localisation with 68Ga-SATO<br /><br>PET/CT imaging compared to M123IBG scintigraphy.<br /><br>- Absolute number of detected lesions and lesions localisation with 68Ga-SATO<br /><br>PET/CT imaging compared to whole body MRI (in case available).<br /><br>- Radiation absorbed dose for whole body and organs using dynamic qualitative<br /><br>PET scanning.<br /><br>- Evaluation of procedure time from administration of 68Ga-SATO till the end of<br /><br>PET-image acquisition. </p><br>