Pulmonary Arterial Hypertension (PAH)Phase 1/2SOFAPINCT07357974
Impact of Sotatercept on Pulmonary Artery and Right Ventricle Remodeling Imaging Assessed With 68Ga-FAPI PET/CT in Patients With PAH
A Phase 1/2 study testing [68Ga]Ga-FAPI PET/CT and [68Ga]Ga-MAA PET/CT in people with Pulmonary Arterial Hypertension (PAH), run by University Hospital, Brest at 1 site in France.
Trial summary
Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterized by structural changes in the pulmonary arteries, leading to increased pulmonary vascular resistance and elevated pulmonary arterial pressure and, if untreated, right heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- [68Ga]Ga-FAPI PET/CT and [68Ga]Ga-MAA PET/CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2026to 1 Jan 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- 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:
- Idiopathic PAH
- Heritable PAH
- Drug/toxine-induced PAH
- PAH associated with connective tissue disease
Show all 12Show fewer
- 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
Who cannot join
- Diagnosis of PH WHO Groups 2, 3, 4, or 5
- 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.
- Hemoglobin at screening above gender-specific ULN, per local laboratory test
- Pregnant or breastfeeding women
- Any of the following clinical laboratory values at the Screening visit:
- eGFR < 30 mL/min/1.73 m2 (as defined by MDRD equation)
Show all 9Show fewer
- Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels > 3 × ULN
- Platelet count < 50,000/mm3 (< 50.0 × 109/L)
- Known allergic reaction to sotatercept (ACE-011), its excipients, or luspatercept
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Sotatercept on Pulmonary Artery and Right Ventricle Remodeling Imaging Assessed With 68Ga-FAPI PET/CT in Patients With PAH: a Pilot Study
Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterized by structural changes in the pulmonary arteries, leading to increased pulmonary vascular resistance and elevated pulmonary arterial pressure and, if untreated, right heart failure. Diagnosis requires a comprehensive evaluation, including right heart catheterization performed in specialized centers.
Despite advances in the understanding and management of the disease, PAH remains a severe condition. Current approved therapies primarily target three key pathways involved in endothelial dysfunction: the endothelin, nitric oxide, and prostacyclin pathways. Pulmonary arterial remodeling is characterized by alterations in endothelial cells, smooth muscle cells, and fibroblasts, with fibroblast activation and macrophage involvement contributing to disease progression.
Read more
Two positron emission tomography/computed tomography (PET/CT) imaging approaches are currently under investigation in PAH. [⁶⁸Ga]Ga-FAPI PET/CT targets activated fibroblasts and enables noninvasive assessment of fibroblast activity and tissue remodeling. [⁶⁸Ga]Ga-MAA lung perfusion PET/CT is an emerging imaging technique that provides higher spatial resolution and sensitivity than conventional lung perfusion imaging and allows evaluation of regional pulmonary perfusion.
Sotatercept is a novel fusion protein that modulates signaling within the transforming growth factor-beta (TGF-β) superfamily by binding select ligands involved in vascular remodeling. Its mechanism of action is distinct from that of currently approved PAH therapies. Sotatercept has been evaluated in clinical development programs, including the PULSAR and STELLAR studies. Reported adverse events include epistaxis, dizziness, increased hemoglobin levels, and changes in blood pressure.
This study is designed with the following objectives:
Primary objective: To assess pulmonary vascular remodeling in patients with PAH using [⁶⁸Ga]Ga-FAPI PET/CT imaging.
Secondary objectives: To evaluate [⁶⁸Ga]Ga-FAPI uptake and regional lung perfusion using [⁶⁸Ga]Ga-MAA lung perfusion PET/CT imaging at predefined study time points.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- [68Ga]Ga-FAPI PET/CT, [68Ga]Ga-MAA PET/CT
- Keywords
- [68Ga]Ga-FAPI PET/CT (FAPI), [68Ga]Ga-MAA lung perfusion PET/CT
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-FAPI PET/CTDiagnostic test
[68Ga]Ga-FAPI PET/CT
[68Ga]Ga-MAA PET/CTDiagnostic test
[68Ga]Ga-MAA PET/CT
| Study group | Role | What they receive |
|---|---|---|
| PET/CT | Experimental | Not described Receives: Diagnostic Test: [68Ga]Ga-FAPI PET/CT; Diagnostic Test: [68Ga]Ga-MAA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular remodeling as assessed by [68Ga] Ga-FAPI uptake of pulmonary arteries on PET/CT imaging.
A positive uptake will be defined as a ratio of the Standardized uptake value (SUV) max of the pulmonary arteries and the SUVmean of the vascular background activity measured at the center of the left ventricle greater than 1.5.
Measured: at baseline
Secondary outcomes (23)
Change from baseline in [68Ga] Ga-FAPI uptake on pulmonary arteries as assessed by SUVmax at 24 weeks.
[68Ga] Ga-FAPI uptake on pulmonary arteries. This will be assessed using a visual scale and the Standardized uptake value (SUVmax).
Measured: At baseline and at 24 weeks.
Visual assessment of pulmonary artery [68Ga]Ga-FAPI uptake
Change from baseline in regional lung perfusion as assessed by the Pulmonary vascular obstruction index (PVOI) (in %) on [68Ga]Ga-MAA lung perfusion PET/CT imaging at 24 weeks.
Measured: At baseline and at 24 weeks.
[68Ga] Ga-FAPI uptake on the right ventricule (RV) assessed by SUVmax at 24 weeks.
Measured: At week 24
RV ventricule dysfunction based on Tricuspid annular plane systolic excursion (TAPSE)<17mm at 24 weeks.
Measured: At 24 weeks.
Change from baseline in [68Ga] Ga-FAPI uptake on the RV as assessed by SUVmax at 24 weeks.
Measured: At baseline and at 24 weeks.
Mean pulmonary arterial pressure (mPAP) (in mmHg) at baseline.
mPAP will be measured by right Heart catheterism (RHC).
Measured: At baseline.
Cardiac output (CO) (l/mn) at baseline.
CO will be measured by RHC.
Measured: At baseline.
Right atrial pressure (RAP) (mmHg) at baseline.
RAP will be measured by RHC.
Measured: at baseline
Right ventricular pressure (RVP) (mmHg) at baseline.
CO will be measured by RHC.
Measured: At baseline.
Pulmonary vascular resistance (PVR) (Wood unit) at baseline.
CO will be measured by RHC.
Measured: At baseline.
Mean pulmonary arterial pressure (mPAP) (mmHg) at 24 weeks.
mPAP will be measured by right Heart catheterism (RHC).
Measured: At 24 weeks.
Cardiac output (CO) (l/mn) at 24 weeks.
CO will be measured by RHC.
Measured: At 24 weeks.
Right atrial pressure (RAP) (mmHg) at 24 weeks.
RAP will be measured by RHC.
Measured: At 24 weeks.
Right ventricular pressure (RVP) (mmHg) at 24 weeks.
CO will be measured by RHC.
Measured: at baseline
6 minutes walking test result (6MWT) (meters) at baseline.
Measured: At baseline.
Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with Nt-proBNP measure in PAH patients
[68Ga] Ga-FAPI uptake on pulmonary arteries (SUVmax) will be correlated with Nt-proBNP measure in PAH patients
Measured: at baseline
6 minutes walking test result (6MWT) (meters) at 24 weeks.
Measured: At 24 weeks.
NYHA functional class at baseline.
The New York heart association (NYHA) scale will be used to classify the severity of the heart failure impact. Classes are defined as I, II, III, IV, with IV indicating severe limitations
Measured: At baseline.
NYHA functional class at 24 weeks.
The New York heart association (NYHA) scale will be used to classify the severity of the heart failure impact extent of heart failure. Classes are defined as I, II, III, IV, with IV indicating severe limitations.
Measured: At 24 weeks.
N-terminal pro B natriuretic peptide (NT-pro-BNP) (pg/ml) at baseline
biological mark indicating heart failure and impact on PH prognosis
Measured: At baseline.
N-terminal pro B natriuretic peptide (NT-pro-BNP) (pg/ml) at 24 weeks.
biological mark indicating heart failure and impact on PH prognosis
Measured: At 24 weeks.
Quality of life (QOL) assessed by emPHasis-10 scale at baseline.
The emPHasis-10 ranges from 0 to 50, with a higher score indicating a poorer health status and QOL.
Measured: At baseline.
QOL assessed by emPHasis-10 scale at 24 weeks.
The emPHasis-10 ranges from 0 to 50, with a higher score indicating a poorer health status and QOL.
Measured: At 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Jul 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This pilot study explores innovative imaging techniques, including \[⁶⁸Ga\]Ga-FAPI PET/CT and \[⁶⁸Ga\]Ga-MAA lung perfusion PET/CT , which have not yet been fully evaluated in patients with pulmonary arterial hypertension. Patients with an indication for sotatercept will be screened for eligibility according to predefined inclusion criteria. Eligible participants will be enrolled in the study. Each participant will undergo a comprehensive assessment including \[⁶⁸Ga\]Ga-FAPI PET/CT and \[⁶⁸Ga\]Ga-MAA PET/CT at baseline and at a follow-up visit 24 weeks later.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cécile Tromeur, Principal investigator, CHU BREST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357974
- Sponsor's protocol ID
- 29BRC24.0296
- Acronym
- SOFAPI
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2025
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sotatercept on Pulmonary Artery and Right Ventricle Remodeling Imaging Assessed With 68Ga-FAPI PET/CT in Patients With PAH: a Pilot Study
- ClinicalTrials.gov ID
- NCT07357974
- Acronym / sponsor ID
- SOFAPI / 29BRC24.0296
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- [68Ga]Ga-FAPI PET/CT (FAPI), [68Ga]Ga-MAA lung perfusion PET/CT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulmonary arterial hypertension (PAH) is a rare, progressive disease characterized by structural changes in the pulmonary arteries, leading to increased pulmonary vascular resistance and elevated pulmonary arterial pressure and, if untreated, right heart failure. Diagnosis requires a comprehensive evaluation, including right heart catheterization performed in specialized centers.
Despite advances in the understanding and management of the disease, PAH remains a severe condition. Current approved therapies primarily target three key pathways involved in endothelial dysfunction: the endothelin, nitric oxide, and prostacyclin pathways. Pulmonary arterial remodeling is characterized by alterations in endothelial cells, smooth muscle cells, and fibroblasts, with fibroblast activation and macrophage involvement contributing to disease progression.
Two positron emission tomography/computed tomography (PET/CT) imaging approaches are currently under investigation in PAH. [⁶⁸Ga]Ga-FAPI PET/CT targets activated fibroblasts and enables noninvasive assessment of fibroblast activity and tissue remodeling. [⁶⁸Ga]Ga-MAA lung perfusion PET/CT is an emerging imaging technique that provides higher spatial resolution and sensitivity than conventional lung perfusion imaging and allows evaluation of regional pulmonary perfusion.
Sotatercept is a novel fusion protein that modulates signaling within the transforming growth factor-beta (TGF-β) superfamily by binding select ligands involved in vascular remodeling. Its mechanism of action is distinct from that of currently approved PAH therapies. Sotatercept has been evaluated in clinical development programs, including the PULSAR and STELLAR studies. Reported adverse events include epistaxis, dizziness, increased hemoglobin levels, and changes in blood pressure.
This study is designed with the following objectives:
Primary objective: To assess pulmonary vascular remodeling in patients with PAH using [⁶⁸Ga]Ga-FAPI PET/CT imaging.
Secondary objectives: To evaluate [⁶⁸Ga]Ga-FAPI uptake and regional lung perfusion using [⁶⁸Ga]Ga-MAA lung perfusion PET/CT imaging at predefined study time points.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This pilot study explores innovative imaging techniques, including [⁶⁸Ga]Ga-FAPI PET/CT and [⁶⁸Ga]Ga-MAA lung perfusion PET/CT , which have not yet been fully evaluated in patients with pulmonary arterial hypertension. Patients with an indication for sotatercept will be screened for eligibility according to predefined inclusion criteria. Eligible participants will be enrolled in the study. Each participant will undergo a comprehensive assessment including [⁶⁸Ga]Ga-FAPI PET/CT and [⁶⁸Ga]Ga-MAA PET/CT at baseline and at a follow-up visit 24 weeks later.
| Arm | Type | Receives |
|---|---|---|
| PET/CT | Experimental | Diagnostic Test: [68Ga]Ga-FAPI PET/CT, Diagnostic Test: [68Ga]Ga-MAA PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- 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:
- Patients under bi or tri-background-therapy
- Symptomatic PAH classified WHO FC II or III
- Patients will be started on Sotatercept
Key exclusion criteria (9 listed)
- Diagnosis of PH WHO Groups 2, 3, 4, or 5
- 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.
- Hemoglobin at screening above gender-specific ULN, per local laboratory test
- Pregnant or breastfeeding women
- Any of the following clinical laboratory values at the Screening visit:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [68Ga]Ga-FAPI PET/CT[68Ga]Ga-FAPI PET/CT | Diagnostic test | PET/CT |
| [68Ga]Ga-MAA PET/CT[68Ga]Ga-MAA PET/CT | Diagnostic test | PET/CT |
Primary outcome
Vascular remodeling as assessed by [68Ga] Ga-FAPI uptake of pulmonary arteries on PET/CT imaging.
Time frame: at baseline
A positive uptake will be defined as a ratio of the Standardized uptake value (SUV) max of the pulmonary arteries and the SUVmean of the vascular background activity measured at the center of the left ventricle greater than 1.5.
23 secondary outcomes
Change from baseline in [68Ga] Ga-FAPI uptake on pulmonary arteries as assessed by SUVmax at 24 weeks.
Time frame: At baseline and at 24 weeks.
Visual assessment of pulmonary artery [68Ga]Ga-FAPI uptake
Time frame: At baseline and at 24 weeks.
[68Ga] Ga-FAPI uptake on the right ventricule (RV) assessed by SUVmax at 24 weeks.
Time frame: At week 24
RV ventricule dysfunction based on Tricuspid annular plane systolic excursion (TAPSE)<17mm at 24 weeks.
Time frame: At 24 weeks.
Change from baseline in [68Ga] Ga-FAPI uptake on the RV as assessed by SUVmax at 24 weeks.
Time frame: At baseline and at 24 weeks.
Mean pulmonary arterial pressure (mPAP) (in mmHg) at baseline.
Time frame: At baseline.
Cardiac output (CO) (l/mn) at baseline.
Time frame: At baseline.
Right atrial pressure (RAP) (mmHg) at baseline.
Time frame: at baseline
Right ventricular pressure (RVP) (mmHg) at baseline.
Time frame: At baseline.
Pulmonary vascular resistance (PVR) (Wood unit) at baseline.
Time frame: At baseline.
Mean pulmonary arterial pressure (mPAP) (mmHg) at 24 weeks.
Time frame: At 24 weeks.
Cardiac output (CO) (l/mn) at 24 weeks.
Time frame: At 24 weeks.
Right atrial pressure (RAP) (mmHg) at 24 weeks.
Time frame: At 24 weeks.
Right ventricular pressure (RVP) (mmHg) at 24 weeks.
Time frame: at baseline
6 minutes walking test result (6MWT) (meters) at baseline.
Time frame: At baseline.
Vascular remodeling on [68Ga]Ga-FAPI PET/CT is correlated with Nt-proBNP measure in PAH patients
Time frame: at baseline
6 minutes walking test result (6MWT) (meters) at 24 weeks.
Time frame: At 24 weeks.
NYHA functional class at baseline.
Time frame: At baseline.
NYHA functional class at 24 weeks.
Time frame: At 24 weeks.
N-terminal pro B natriuretic peptide (NT-pro-BNP) (pg/ml) at baseline
Time frame: At baseline.
N-terminal pro B natriuretic peptide (NT-pro-BNP) (pg/ml) at 24 weeks.
Time frame: At 24 weeks.
Quality of life (QOL) assessed by emPHasis-10 scale at baseline.
Time frame: At baseline.
QOL assessed by emPHasis-10 scale at 24 weeks.
Time frame: At 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cécile Tromeur principal investigator
CHU BREST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing [68Ga]Ga-FAPI PET/CT and [68Ga]Ga-MAA PET/CT in people with Pulmonary Arterial Hypertension (PAH), run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile Tromeur (+33230337602, Cecile.tromeur@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular remodeling as assessed by [68Ga] Ga-FAPI uptake of pulmonary arteries on PET/CT imaging. (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.