AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This study, called SoFAPI, is looking at a condition called Pulmonary Hypertension (PAH), which affects the blood vessels in the lungs and the right side of the heart. We are using a special type of scan called a PET/CT with a tracing medicine called 68Ga-FAPI. The main goal is to see if this special medicine lights up in the lung blood vessels of people with PAH. We will also check if it lights up in the right side of the heart. Later, we'll see how these things change after patients have been treated for 24 weeks with another new medicine called Winrevair. We hope this research will help us better understand and treat PAH.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Enrolment target

Start

24 Oct 2025

Pulmonary arterial hypertension (PAH)

What is this study about?

This research study, called the SoFAPI study, is looking into a lung condition known as Pulmonary Hypertension (PAH). In PAH, the blood vessels in your lungs become narrowed or blocked, making it harder for your heart to pump blood through them. This can put a strain on the right side of your heart.

The study uses a special imaging technique called a PET/CT scan. For this scan, a very small, safe amount of a tracer medicine called 68Ga-FAPI is given. This tracer helps parts of your body show up more clearly on the scan. We want to see if this tracer lights up in the blood vessels of the lungs and the right side of the heart in people with PAH. This 'lighting up' could tell us more about how the disease is affecting these parts of the body.

After an initial scan, some patients in the study will receive a medicine called Winrevair (which comes in different strengths, 45mg or 60mg) for 24 weeks. We will then do follow-up scans to see if the way the tracer lights up has changed after treatment. We'll also compare these scan results with other measures like how far a person can walk in six minutes, their quality of life, and other heart tests. By doing this, we hope to learn if these special scans can help doctors understand how PAH is progressing and how well new treatments like Winrevair are working.

Key takeaways

This study is for people with Pulmonary Hypertension (PAH).
It uses a special PET/CT scan with a tracer called 68Ga-FAPI.
The study aims to see how PAH affects lung blood vessels and the heart.
It also checks how a new medicine, Winrevair, changes these findings over 24 weeks.
Results may help doctors better understand and treat PAH in the future.

Who may be eligible?

To be able to take part in this study, you must be at least 18 years old. The study is open to both men and women.

We are specifically looking for people who have been diagnosed with Pulmonary Arterial Hypertension (PAH).

There might be other health conditions or medications that would mean you couldn't join the study, but the healthcare team would discuss all these details with you to see if you are a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged 18 or over?
Have you been diagnosed with Pulmonary Arterial Hypertension (PAH)?
Are you able to attend clinic visits and undergo scans?
Are you comfortable with receiving injections?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits to the clinic over a period of time. At your first visit, you'll have a special PET/CT scan where you'll be given a small amount of a tracer medicine directly. This scan will look at your lung arteries and the right side of your heart.

Some participants will then start a new medicine called Winrevair, which comes as an injection, and continue this treatment for 24 weeks. During this treatment period, you will have follow-up visits. At around week 24, you will have another PET/CT scan, similar to the first one, to see if there have been any changes in your lung arteries and heart after taking the medicine. You might also have another type of PET/CT scan for lung 'perfusion' which checks blood flow, as well as blood tests, walking tests, and questionnaires about your health and quality of life. The total duration of your active participation, including follow-up, would be around 24 weeks from starting treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit by giving you access to new and specialized monitoring techniques and possibly a new treatment for Pulmonary Hypertension. While we hope for positive outcomes, there are no guarantees benefits will apply directly to you. Potential risks include discomfort from injections, side effects from the Winrevair medicine (which the doctors will discuss with you), and exposure to a small amount of radiation from the PET/CT scans. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Pulmonary Hypertension (PAH)?

It's a serious lung condition where blood vessels in the lungs become narrow, making it hard for the heart to pump blood, which can strain the right side of the heart.

What is a PET/CT scan?

It's a special type of scan that helps doctors see what's happening inside your body in more detail, using a small amount of a safe tracer medicine.

What is 68Ga-FAPI?

It's a special tracing medicine used in the PET/CT scan to highlight certain areas, like the blood vessels in your lungs, to help doctors see them better.

What is Winrevair?

Winrevair is a new medicine being tested in this study for the treatment of Pulmonary Hypertension.

How long will I be in the study?

If you receive treatment in the study, your active participation, including scans and follow-up, will be for about 24 weeks.