Neuroblastoma MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 68GA-SATOREOTIDE TRIZOXETAN
Product Code: 68GA-SSO120
Pharmaceutical Form: Solution for injection
Sponsors
Princess Maxima Center for pediatric oncology
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: Assess the short term safety and tolerability of 68Ga-SATO in pediatric patients with NBL;Secondary Objective: Comparison of 68Ga-SATO PET/CT imaging to the current clinical standard of M123IBG scintigraphy in NBL patients, in terms of lesions detection. - Comparison of 68Ga-SATO PET/CT imaging to whole body MRI (in case available), in terms of lesions detection. - To calculate, in a subset of patients, the radiation absorbed dose of 68Ga-SATO for patients using dynamic PET imaging. - Evaluation of procedure time for the preparations and acquisition of a 68Ga-SATO;Primary end point(s): Adverse events according to CTCAE v5.0 encountered after [68GA]-SATOREOTIDE TRIZOXETAN injection.;Timepoint(s) of evaluation of this end point: Up to 1 hour post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number and localisation of neuroblastoma lesions detected with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to [123I]mIBG SPECT, segment based according to SIOPEN for skeletal lesions and absolute number of detected soft tissue lesions with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to [123I]mIBG SPECT. 2. Number and localisation of neuroblastoma lesions detected with [68GA]-SATOREOTIDE TRIZOXETAN PET-CT compared to whole body MRI (if available), absolute number of detected skeletal and soft tissue lesions. 3. Radiation absorbed dose of 68GA-SATOREOTIDE TRIZOXETAN from patients that underwent dynamic PET imaging.;Timepoint(s) of evaluation of this end point: 1. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT 2. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT 3. Post acquisition of [68GA]-SATOREOTIDE TRIZOXETAN PET-CT | — |
Countries
Netherlands
Contacts
Public ContactNuclear Medicine Physician
Princess Maxima Center for pediatric oncology
Outcome results
None listed