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68Ga-FAPI PET/CT imaging to assess pulmonary artery and right ventricle remodeling SoFAPI study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520731-17-02
Acronym
29BRC24.0296
Enrollment
15
Registered
2025-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary arterial hypertension (PAH)

Brief summary

[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.

Detailed description

[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), [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with 6 minutes walking test result (6MWT) in PAH patients, [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with NYHA functional class in PAH patients, [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with Nt-proBNP measure in PAH patients, [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with quality of life (Emphasis 10) measure in PAH patients, Qualitative and quantitative evaluation of imaging parameters, including image quality and reproducibility, acquisition time, radiation dose, ease of interpretation, technical success rate, inter-operator variability, and the impact of acquisition parameters on biomarker quantification.

Interventions

DRUGWinrevair 60 mg powder and solvent for solution for injection
DRUGWinrevair 45 mg powder and solvent for solution for injection

Sponsors

Centre Hospitalier Regional Et Universitaire De Brest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
[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.

Secondary

MeasureTime frame
[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), [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with 6 minutes walking test result (6MWT) in PAH patients, [68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with NYHA functional class in PAH patients, [68Ga] Ga-FAPI uptake on pulmonar

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026