Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
neuroblastoma
Assess the short term safety and tolerability of 68Ga-SATO in pediatric patients with NBL
Key facts
- Sponsor
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 28 Feb 2023 → ongoing
- Decision date (initial)
- 2024-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-513843-10-00
- EudraCT number
- 2022-001811-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
Assess the short term safety and tolerability of 68Ga-SATO in pediatric patients with NBL
Secondary objectives 4
- Comparison of 68Ga-SATO PET/CT imaging to the current clinical standard of M123IBG scintigraphy in NBL patients, in terms oflesions 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
Conditions and MedDRA coding
neuroblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029260 | Neuroblastoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- 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 M123IBGimaging and patients with known NBL who are referred for for follow-up M123IBG imaging
Exclusion criteria 4
- Children with pre-existing severe auto-immune diseases.
- Use of therapeutic long-acting somatostatin analogs (e.g. Sandostatin®, Lanreotide®) within the 21 days beforethe planned infusion of 68Ga-SATO
- Use of diuretics within 24 hours before the planned infusion of 68Ga-SATO.
- pregnancy of the patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To assess the short term safety and tolerability of 68Ga-SATO, according to CTCAE v5.0.
Secondary endpoints 4
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11621054 · Product
- Active substance
- Satoreotide Trizoxetan Gallium (GA68)
- Substance synonyms
- SATOREOTIDE TRIZOXETAN GALLIUM GA-68, OPS-202 GA-68, 68Ga-2,2'-(7-(4-((S)-1-((4S,7S,10S,13R,16S,19R)-4-((R)-1-amino-3-(4-hydroxyphenyl)-1-oxopropan-2-ylcarbamoyl)-10-(4-aminobutyl)-16-(4-((S)-2,6-dioxohexahydropyrimidine-4-carboxamido)benzyl)-7-((R)-1-hydroxyethyl)-6,9,12,15,18-pentaoxo-13-(4-ureidobenzyl)-1,2-dithia-5,8,11,14,17-pentaazacycloicosan-19-ylamino)-3-(4-chlorophenyl)-1-oxopropan-2-ylamino)-1-carboxy-4-oxobutyl)-1,4,7-triazonane-1,4-diyl)diacetic acid
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- PRINSES MAXIMA CENTRUM VOOR KINDERONCOLOGIE B.V.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
—
SCP18777979 · ATC
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- V09IX01 — IOBENGUANE (123I)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Prinses Maxima Centrum voor Kinderoncologie B.V.
- Sponsor organisation
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Address
- Heidelberglaan 25
- City
- Utrecht
- Postcode
- 3584 CS
- Country
- Netherlands
Scientific contact point
- Organisation
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Contact name
- Arthur Braat
Public contact point
- Organisation
- Prinses Maxima Centrum voor Kinderoncologie B.V.
- Contact name
- Yvonne Ruchti
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Prinses Maxima Centrum voor Kinderoncologie B.V.
TDC, Heidelberglaan 25, 3584 CS, Utrecht
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-02-28 | 2024-10-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_GAP_NBL_Protocol_signed_Redacted | 2-0 |
| Recruitment arrangements (for publication) | GAPNBL_Blanc Transition Document | 1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_12-16eo_Redacted | 2-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_Parents_Redacted | 2-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL16eo_Redacted | 2-0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_GAP_NBL_SmPC_AdreView_Iobenguane_Injectionsolution | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Netherlands | Acceptable with conditions 2024-10-11
|
2024-10-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-17 | Netherlands | Acceptable with conditions 2024-10-11
|
2025-06-17 |