2025-520731-17-02RecruitingPhase 3

SOFAPI

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

Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Sept 2026

Brief summary (registry, in English)

Our first objective is to assess whether [68Ga]Ga-FAPI PET/CT imaging can non-invasively assess pulmonary artery remodeling in PAH patients.

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pulmonary arterial hypertension (PAH) who are about to start sotatercept, to test a PET/CT scan with 68Ga-FAPI.

Age: 18 years or older
Sex: All sexes
Disease stage: Symptomatic PAH, WHO functional class II or III. PAH types: idiopathic, heritable, drug/toxin-induced, linked to connective tissue disease, or linked to simple congenital shunts at least 1 year after repair. A right heart catheterization within 12 months must show PVR of at least 4 Wood units and PCWP or LVEDP of 15 mmHg or less.
Earlier treatment: Already on double or triple background PAH therapy, and about to be started on Sotatercept.

PH of WHO Groups 2, 3, 4 or 5
HIV-associated PAH, PAH with portal hypertension, schistosomiasis-associated PAH, pulmonary veno-occlusive disease or pulmonary capillary hemangiomatosis
Pregnant or breastfeeding women
eGFR below 30 mL/min/1.73 m2, or ALT, AST or total bilirubin above 3 × ULN
Known allergy to sotatercept (ACE-011), its excipients, or luspatercept

Read by machine on 9 Nov 2026.

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH, PAH associated with portal hypertension, schistosomiasis associated PAH, pulmonary veno occlusive disease and pulmonary capillary hemangiomatosis
A known allergy has been identified with sotatercept (ACE-011), its excipients, or luspatercept.

Hemoglobin at screening above gender-specific ULN, per local laboratory test
Any of the following clinical laboratory values at the Screening Visit: - eGFR < 30 mL/min/1.73 m2 (as defined by MDRD equation) - Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 3 × ULN

18 years old or more
Documented diagnostic right heart catheterization (RHC) within 12 months of screening documenting a minimum PVR of ≥ 4 Wood units and pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) of ≤ 15 mmHg, with the diagnosis of WHO PAH Group 1 in any of the following subtypes: o Idiopathic PAH o Heritable PAH o Drug/toxine-induced PAH o PAH associated with connective tissue disease o PAH associated with simple, congenital systemic-to- pulmonary shunts at least 1year following repair
Patients under bi or tri-background-therapy
Symptomatic PAH classified WHO FC II or III
Patients will be started on Sotatercept
Ability to adhere to study visit schedule and understand and comply with all the protocol requirement.
Ability to understand and provide written informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Centre Hospitalier Régional et Universitaire de Brest	Brest	France	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.