SYF73121df504a6488caf45d815900f79e1Registry ID: 2025-520731-17-02|Not Yet RecruitingPhase 3
SOFAPI
68Ga-FAPI PET/CT imaging to assess pulmonary artery and right ventricle remodeling SoFAPI study
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68Ga-FAPI PET/CT imaging to assess pulmonary artery and right ventricle remodeling SoFAPI study
interventional
N/A
1 country
1
Our first objective is to assess whether [68Ga]Ga-FAPI PET/CT imaging can non-invasively assess pulmonary artery remodeling in PAH patients.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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July 3, 2025
Actual (reported)[68Ga] Ga-FAPI uptake (Yes/No) of pulmonary arteries on PET/CT imaging in patients with PAH at V0. The uptake will be assessed visually and outcome considered as success by consensus of two nuclear medicine physicians, using the surrounding vascular background as a reference.
[68Ga] Ga-FAPI uptake on pulmonary arteries at V1 and V2(after 24 weeks treatment with Sotatercept). This will be assessed using a visual scale and the Standardized uptake value (SUVmax).
Regional lung perfusion will be assessed by quantifying the Pulmonary vascular obstruction index (PVOI) on [68Ga]Ga-MAA lung perfusion PET/CT at V1 and V2 (after 24 weeks treatment with Sotatercept)
[68Ga] Ga-FAPI uptake on the RV (SUVmax) and a RV ventricule dysfunction based on Tricuspid annular plane systolic excursion (TAPSE)<17mm.
[68Ga] Ga-FAPI uptake on the RV (SUVmax) at V1 and V2
[68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with hemodynamic parameters on RHC (PAPm, CO, RAP, RVP, PVR)
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Formulated product
Winrevair 60 mg powder and solvent for solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Winrevair 45 mg powder and solvent for solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Winrevair 60 mg powder and solvent for solution for injection
Named ingredient: sotatercept
View registry recordWinrevair 45 mg powder and solvent for solution for injection
Named ingredient: sotatercept
View registry recordCentre Hospitalier Regional Et Universitaire De Brest
Brest, 29200, France
Fouad abdelillah
First Submitted
July 3, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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