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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513843-10-00
Acronym
PS21GAP
Enrollment
20
Registered
2024-10-11
Start date
2023-02-28
Completion date
Unknown
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neuroblastoma

Brief summary

To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.

Detailed description

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

Interventions

DRUGIOBENGUANE (123I)
DRUG68Ga-SSO120

Sponsors

Prinses Maxima Centrum voor Kinderoncologie B.V.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.—

Secondary

MeasureTime frame
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—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026