(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 Giant cell arteritis | Polymyalgia rheumatica

Inclusion criteria

• {"criterion_text":"- Patients with suspected GPSD. In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n- Age ≥ 50 years\n- Patients must be able to adhere to the study appointments and other protocol requirements.\n- Patients must be capable of giving informed consent"}

Exclusion criteria

• {"criterion_text":"- Patients with suspected GPSD. A potential subject who meets any of the following criteria will be excluded from participation in this study:\n- Suspected GPSD,\n- Presence of symptoms, imaging test result or biopsy findings suggesting cranial artery involvement in GPSD (‘cranial giant cell arteritis’)\n- Use of oral glucocorticoid treatment or disease modifying anti-rheumatic drugs at time of inclusion\n- Females with child bearing potential. Post-menopausal women with >12 months of amenorrhoea are considered to have no child bearing potential. Given the age distribution of patients with GPSD, exclusion of females with child bearing potential will not lead to recruitment bias in the study.\n- Research-related radiation exposure (cumulative ≥5 mSv) in the year before inclusion."}

Primary endpoints

• {"endpoint_text":"- The diagnostic accuracy of 68Ga-FAPI-46 PET/CT in patients with suspected GPSD.","definition_or_measurement_approach":"Assess diagnostic accuracy of 68Ga-FAPI-46 PET/CT; specific measurement/definition details not provided in the available metadata."}

Secondary endpoints

• {"endpoint_text":"- 68Ga-FAPI-46 uptake after 28 days of standard treatment in patients with GPSD.","definition_or_measurement_approach":"Measure 68Ga-FAPI-46 uptake after 28 days; specific quantification/measurement methods not detailed in the provided metadata."}
• {"endpoint_text":"- 68Ga-FAPI-46 uptake after 6 months of standard treatment in patients with GPSD","definition_or_measurement_approach":"Measure 68Ga-FAPI-46 uptake after 6 months; specific quantification/measurement methods not detailed in the provided metadata."}

Netherlands

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

14-04-2026

Processing Time Days

15

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Siemens Healthineers","duties_or_roles":"Monetary support","organisation_type":""}