Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruiting
Participants planned
58
Countries
1
Sites
1
(suspision on) Neuroblastoma
To compare the diagnostic performance of [18F]mFBG PET-CT to conventional [123I]mIBG SPECT-CT for the detection of skeletal lesions in patients with neuroblastoma
Key facts
- Sponsor
- Princess Maxima Center For Pediatric Oncology
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 12 Nov 2024 → ongoing
- Decision date (initial)
- 2024-09-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- KiKa (Foundation)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Efficacy
To compare the diagnostic performance of [18F]mFBG PET-CT to conventional [123I]mIBG SPECT-CT for the detection of skeletal lesions in patients with neuroblastoma
Secondary objectives 4
- To compare the diagnostic performance of [18F]mFBG PET-CT to conventional [123I]mIBG SPECT-CT for the detection of soft tissue lesions in patients with neuroblastoma
- To calculate, in a subset of patients that undergo dynamic PET scanning, the absorbed radiation dose of [18F]mFBG in normal organs and tumour lesions
- To assess interobserver agreement and reliability for lesion detection on [18F]mFBG PET-CT
- To establish reference values for [18F]mFBG uptake for different tissues
Conditions and MedDRA coding
(suspision on) Neuroblastoma
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2019-003713-33 | Diagnostic accuracy of neuroblastoma patient imaging with [18F]-mFBG PET-CT compared to [123]I-mIBG scanning , Diagnostische nauwkeurigheid van beeldvorming van neuroblastoompatiënten met [18F]mFBG PET-CT in vergelijking met [123I]mIBG beeldvorming. | |
| 2022-501694-39-00 | A Prospective Study Comparing [18F]mFBG PET-CT to [123I]mIBG Scanning in Neuroblastoma | Princess Maxima Center For Pediatric Oncology |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patient with (a clinical suspicion of) neuroblastoma who is referred for conventional [123I]mIBG imaging
- Written informed consent from patients and/or from parents or legal guardians, according to local law and regulations
Exclusion criteria 2
- [18F]mFBG imaging cannot be scheduled within two weeks of [123I]mIBG imaging
- Pregnancy of patient
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Detected skeletal lesions on [18F]mFBG PET-CT and [123I]mIBG scanning
Secondary endpoints 4
- Detected soft tissue lesions on [18F]mFBG and [123I]mIBG scanning
- Radiation absorbed doses (mSv) for organs and tumour of [18F]mFBG imaging
- Mean difference in number of detected lesions and limits of agreement, Cohen’s kappa
- SUVmean for normal organs, SUVmax for tumour lesions
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
[18F]meta-fluorobenzylguanidine
PRD9915467 · Product
- Active substance
- [18FMETA-FLUOROBENZYLGUANIDINE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Authorisation status
- Not Authorised
- MA holder
- PRINCESS MÁXIMA CENTER FOR PEDIATRIC ONCOLOGY
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/525
Comparator 1
SCP18777979 · ATC
- Active substance
- Iodine (123I) Iobenguane
- Substance synonyms
- IOBENGUANE I 123, Iobenguane (123I)
- Route of administration
- SOLUTION FOR INJECTION
- Authorisation status
- Authorised
- ATC code
- V09IX01 — IOBENGUANE (123I)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/07/525
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Princess Maxima Center For Pediatric Oncology
- Sponsor organisation
- Princess Maxima Center For Pediatric Oncology
- Address
- Heidelberglaan 25
- City
- Utrecht
- Postcode
- 3584 CS
- Country
- Netherlands
Scientific contact point
- Organisation
- Princess Maxima Center For Pediatric Oncology
- Contact name
- Prof. Dr. G.A.M. Tytgat
Public contact point
- Organisation
- Princess Maxima Center For Pediatric Oncology
- Contact name
- Secretary TDC
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 58 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Princess Maxima Center For Pediatric Oncology
Solid Tumors, 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 | 2024-11-12 | 2025-09-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_[2022-501694-39-01]_redacted | 2-1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_NL | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_12-16 yr_Redacted | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_16 yr and older_Redacted | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_Parents_older child_Redacted | 2-1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_Parents_Redacted | 2-1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_mIBG | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Synopsis_NL[2022-501694-39-01] | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-27 | Netherlands | Acceptable with conditions 2024-09-23
|
2024-09-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-08 | Netherlands | Acceptable with conditions 2025-07-07
|
2025-07-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-16 | Netherlands | Acceptable with conditions 2025-07-07
|
2025-10-16 |