Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Temporarily halted
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 | Temporarily halted | 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 | 2023-04-19 | 2026-06-25 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-141677
- Halt date
- 2026-06-25
- Planned restart
- 2026-09-25
- Member states concerned
- Netherlands
- Publication date
- 2026-07-02
- Reason
- Sponsor decision
- Explanation
- When trying to get hold on the MA holder of the IMP (Ariceum therapeutics) the Sponsor has discovered that Ariceum has applied for "provisional insolvency" (preliminary insolvency) at the courts of Berlin, Germany (the application was received by the Charlottenburg Insolvency Court on 04.12.2025). The Acrieum has not informed the Sponsor of these insolvency proceedings, and the Sponsor has been unable to establish contact. Emails to the Acrieum are undeliverable, and the company's website is no longer accessible.
The Sponsor is currently assessing the potential impact of these insolvency proceedings on the study and its participants. To date, 9 patients have been enrolled in the study and have received the IMP. All of these patients have completed their follow-up and will not receive any additional IMP. Therefore, there is currently no identified risk to these participants. There are no new patients insight at this time.
The Sponsor has decided to temporarily halt the study and suspend further patient enrolment until the potential impact of the insolvency proceedings has been fully assessed. - Follow-up measures
- The Sponsor will place the study on hold, contact the IGJ for advice regarding the case, review the contractual clauses, assess the potential impact on future patient enrolment (if applicable), and evaluate whether the current sample size is sufficient to answer the primary study endpoints.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
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 |