neuroblastoma
Conditions
Interventions
n.a.
an additional 68Ga-SATO PET/CT will be performed, for which the patient
will receive a single bolus injection of the radiopharmaceutical via a
pre-existing intravenous cannula or via a pre-existing
Sponsors
Prinses Máxima Centrum voor Kinderoncologie
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Absolute number of detected lesions and lesion localisation with 68Ga-SATO PET/CT imaging compared to M123IBG scintigraphy. - Absolute number of detected lesions and lesions localisation with 68Ga-SATO PET/CT imaging compared to whole body MRI (in case available). - Radiation absorbed dose for whole body and organs using dynamic qualitative PET scanning. - Evaluation of procedure time from administration of 68Ga-SATO till the end of PET-image acquisition. | — |
Countries
Netherlands
Outcome results
None listed