Overview
Sponsor-declared trial summary
Graves' Orbitopathy
The main objective of this study is to compare the uptake of FAPI (Fibroblast Activation Protein Inhibitor) in patients with active Graves' Ophthalmopathy (GO) versus those with inactive GO. This comparison aims to determine the differential uptake patterns and potential diagnostic value of FAPI in assessing disease ac…
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Eye Diseases [C11], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2025-10-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- SWOO (Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis) Prof.Dr. H.J. Flieringa
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The main objective of this study is to compare the uptake of FAPI (Fibroblast Activation Protein Inhibitor) in patients with active Graves' Ophthalmopathy (GO) versus those with inactive GO. This comparison aims to determine the differential uptake patterns and potential diagnostic value of FAPI in assessing disease activity in GO patients.
Secondary objectives 5
- Compare FAPI uptake in patients with high vs. low levels of TSH-R-Ab.
- Compare FAPI uptake in patients with high vs. low serum concentrations of specific proteins related to GO activity.
- Compare FAPI uptake in patients with active inflammation (on standard MRI) vs. those without.
- Compare FAPI uptake in the right vs. left orbit in patients with unilateral or asymmetric orbitopathy.
- Compare FAPI uptake in patients with reduced vs. normal ocular motility.
Conditions and MedDRA coding
Graves' Orbitopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10057889 | Graves' ophthalmopathy | 10015919 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2025-521163-12-00 | The use of [68Ga]Ga-FAPI PET/MRI in assessing disease activity in patients with Graves’ orbitopathy | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Inclusion of 5 patients with Graves Orbitopathy (GO) and Clinical Activity Score (CAS) >3, consistent with active GO.
- Inclusion of 5 patients with GO who have previously undergone CAS >3, but with a current low CAS of 0 or 1 for at least 6 months (i.e. inactive GO)
Exclusion criteria 2
- General exclusion criteria for MRI, including (but not limited to) claustrophobia, metal-splinters in face-area, recent surgery etc.
- For active GO: if PET-MRI can not be performed <14 days, patient will not be included
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- FAPI uptake in active GO versus inactive GO on PET-MRI
Secondary endpoints 1
- Relation MRI results (edema), clinical symptoms, and lab values to FAPI-uptake on PET.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10114365 · Product
- Active substance
- (S-222-10-2-4-3-4-2-2-CYANO-44-DIFLUOROPYRROLIDIN-1-YL-2-OXOETHYLCARBAMOYL-QUINOLIN-6-YLMETHYLAMINO-PROPYLPIPERAZIN-1-YL-2-OXOETHYL-68GA-14710-TETRAAZACYCLODODECANE-147-TRIYLTRIACETATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- RHPET
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Department of Radiology and Nuclear Medicine
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Department of Radiology and Nuclear Medicine
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521163-12-01_newversion | 1 |
| Protocol (for publication) | D1_Protocol 2025-521163-12-01_TrackChanges | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_newversion | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_trackchanges | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2025-521163-12-01 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NED 2025-521163-12-01 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Netherlands | Acceptable 2025-10-30
|
2025-10-30 |