(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 Idiopathic inflammatory myopathy|Crohn's disease|Ulcerative colitis|Fibrotic hypersensitivity pneumonitis|Idiopathic pulmonary fibrosis|Unclassifiable interstitial lung disease|Systemic sclerosis

Inclusion criteria

• {"criterion_text":"- ≥ 18 years of age and able to undergo a PET/CT-scan and pulmonary function test (if applicable)\n- CD: endoscopically or ultrasonographically confirmed fibrostenotic disease with or without signs of active inflammation\n- UC: therapy-refractory UC requiring surgery or quiescent UC with surveillance endoscopy\n- SSc: SSc with active ILD or non-progressive ILD over two years or end-stage ILD\n- IIM: IIM with active myositis and a clinical need to start imunosupressive agents with or without ILD\n- FHP, uILD and IPF: available chest HRCT data within 12 months prior to screening (or performed at screening), minimum of 20% involvement of the lung parenchyma on HRCT and signs of fibrosis, FVC ≥ 45% predicted from normal, FEV1/FVC ≥ 0.7, DLco corrected for Hb ≥ 40% predicted from normal"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or lactating\n- Not able to provide written consent\n- Previous anti-fibrotic treatment except for end-stage ILD\n- IBD: colorectal carcinoma or high-grade dysplasia\n- ILD: combined pulmonary fibrosis and emphysema, uncontrolled severe asthma, active malignancy (except for squamous cell carcinoma of the skin, low-risk breast cancer and low-risk prostate cancer), signs of upper or lower respitory tract symptoms during the last 6 weeks before screening or circumstances or comorbidities which interfere, by opinion of the investigator, with evaluation of the PET/CT or with the evaluation of progressive pulmonary fibrosis"}

Primary endpoints

• {"endpoint_text":"- Detection of areas with enhanced 68Ga-FAPi uptake in organs of patients with IBD, CTD or ILD and correlation of imaging outcomes to cellular and serum FAP expression levels","definition_or_measurement_approach":"Imaging detection of enhanced 68Ga-FAPi uptake by PET/CT and correlation of imaging outcomes to cellular and serum FAP expression levels (i.e., imaging measures correlated with cellular and serum FAP measurements)."}
• {"endpoint_text":"- Transcriptome and proteome analysis of tissue samples for FAP and other potential fibrotic biomarkers as well as regulators of upstream signaling pathways and immune cell markers.","definition_or_measurement_approach":"Transcriptome and proteome analyses of tissue samples to measure FAP and other fibrotic biomarkers and regulators of upstream signaling pathways and immune cell markers (molecular profiling of tissue samples)."}

Secondary endpoints

• {"endpoint_text":"- Visual and semi-quantitative evaluation of the pharmacokinetics of 68GA-FAPi in patients with CTD and ILD.","definition_or_measurement_approach":"Visual and semi-quantitative assessment of 68Ga-FAPi pharmacokinetics on PET/CT (e.g., uptake patterns and semi-quantitative uptake measures over time)."}
• {"endpoint_text":"- Optimization of the 68Ga-FAPi PET/CT scanning protocol for patients with CTD and ILD.","definition_or_measurement_approach":"Assessment and adjustment of PET/CT scanning parameters/protocols to identify an optimized scanning protocol for these patient groups."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-02-2026

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

4

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Amsterdam UMC Stichting

Organisation Type

Patient organisation/association

Country Of Registered Address

Netherlands