(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-CYANO-4,4-DIFLUOROPYRROLIDIN-1-YL)-2-OXOETHYLCARBAMOYL)-QUINOLIN-6-YL)(METHYL)AMINO)-PROPYL)PIPERAZIN-1-YL)-2-OXOETHYL)-68GA-[1,4,7,10]-TETRAAZACYCLODODECANE-1,4,7-TRIYL)TRIACETATE for Graves' orbitopathy|Graves' ophthalmopathy

Inclusion criteria

• {"criterion_text":"- Inclusion of 5 patients with Graves Orbitopathy (GO) and Clinical Activity Score (CAS) >3, consistent with active GO."}
• {"criterion_text":"- 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

• {"criterion_text":"- General exclusion criteria for MRI, including (but not limited to) claustrophobia, metal-splinters in face-area, recent surgery etc."}
• {"criterion_text":"- For active GO: if PET-MRI can not be performed <14 days, patient will not be included"}

Primary endpoints

• {"endpoint_text":"- FAPI uptake in active GO versus inactive GO on PET-MRI","definition_or_measurement_approach":"Measured as FAPI uptake on PET-MRI comparing patients with active GO (CAS >3) versus inactive GO (CAS 0-1 for ≥6 months)."}

Secondary endpoints

• {"endpoint_text":"- Relation MRI results (edema), clinical symptoms, and lab values to FAPI-uptake on PET.","definition_or_measurement_approach":"Correlation/relationship analyses between MRI edema findings, clinical symptoms, laboratory values (including TSH-R-Ab and specific serum proteins) and FAPI uptake measured on PET."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-10-2025

Latest Decision Or Authorization Date

30-10-2025

Processing Time Days

8

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"SWOO (Stichting Wetenschappelijk Onderzoek Het Oogziekenhuis) Prof.Dr. H.J. Flieringa","duties_or_roles":"Source of monetary support","organisation_type":""}