GAP-NBL (neuroblastoma)
Recruiting
Who can enter
Children with (suspected) neuroblastoma
0-18 years of age
Goal
Goal
The goal of this study is to compare the short-term safety and tolerability of the 68Ga-SATO scan with the current MIBG scan.
Background
Background
In about 80% of children with neuroblastoma, the disease is visible on an MIBG scan, but in about 20% it is not. So not everyone can be monitored with an MIBG scan and besides that, there are several disadvantages to the MIBG scan.
The SATO scan is a more targeted NBL imaging technique that targets a property of NBL, namely the presence of a protein called SSTR (somatostatin receptor). In this study, children will get a 68Ga-SATO PET/CT scan in addition to the standard MIBG scan.
To do this, the child will receive a single bolus injection of the SATO through a pre-existing intravenous cannula or through a pre-existing central line. Ideally, the PET/CT scan should be performed in the same anesthesia session (only in children requiring sedation) as the MIBG scan, the standard diagnostic examination. This extends anesthesia time by 30-40 minutes and does not require additional insertion of an intravenous cannula (for this examination).
Alternative logistically acceptable arrangements are: (a) the 68Ga-SATO PET/CT scan is done on the day of MIBG injection (day prior to MIBG scan; not for children requiring anesthesia) or on the day of an MRI (for patients requiring anesthesia), (b) a separate scan day, not in combination with the standard diagnostic MIBG scan or MRI, as long as the MIBG scan and the 68Ga-SATO PET/CT scan are no more than two weeks apart (only for children not requiring anesthesia).
In order to participate in a study please refer to your/your child’s doctor.
Last reviewed
Last reviewed
March 20, 2026
Study details
- Study details
Official title
68Ga-SATO in paediatric neuroblastoma patient; exploratory, safety, non-randomized, open label, comparativestudy – GAP NBL studyCancer type
NeuroblastomaMaximum number of patients
20, all of whom in the NetherlandsStart date
March 2, 2023Status
OpenLocal principal investigator
Dr. A.J.A.T. BraatSponsor
Princess Máxima Center for pediatric oncologyApproval
The study of this new treatment has been reviewed by an accredited medical research ethics committee. This committee has decided that it is justified to ask patients to participate in this study. More information can be found at: CCMO.Trial registry number
EU clinical trial register: 2022-001811-16
The above information is intended as a brief summary only and may not reflect the most up-to-date information. For full details and the current status of a protocol, physicians can contact the Princess Máxima Center directly.