AuthorisedTherapeutic exploratory (Phase II)Interventional

Accuracy for Imaging Cardiac Sarcoidosis with 68Ga-Pentixafor Positron Emission Tomography/Computed Tomography (68Ga-Pentixafor PET/CT): ASPECT study

This research, called the ASPECT study, is investigating a new imaging test, 68Ga-Pentixafor PET/CT, for people with suspected or known cardiac sarcoidosis. Cardiac sarcoidosis is a condition where small clumps of inflammatory cells, called granulomas, grow in the heart, which can affect its function. The study aims to see how accurate this new scan is at identifying these cells compared to the standard scan, 18F-FDG PET/CT. Doctors hope this new scan will give them a better and more reliable way to detect and understand this heart condition, ultimately helping patients get the right treatment.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

12 Feb 2026

Cardiac Sarcoidosis

What is this study about?

This study, called ASPECT, is looking for a better way to diagnose and understand a heart condition called cardiac sarcoidosis. This condition involves tiny clusters of inflammatory cells growing in the heart, which can cause various heart problems. Currently, doctors often use a scan called an 18F-FDG PET/CT. This study is testing a newer type of scan, called 68Ga-Pentixafor PET/CT.

The main goal is to find out if this new 68Ga-Pentixafor PET/CT scan is more accurate than the standard scan at finding these inflammatory cells in the heart. The researchers will compare the results from both scans to see how well the new one works. They will look at how much of the special tracer liquid used in the scan is taken up by the heart and where exactly it shows up. By doing this, they hope to get a clearer picture of the condition.

Developing better ways to identify cardiac sarcoidosis is very important. A more accurate scan could help doctors diagnose the condition earlier, guide treatment decisions more effectively, and improve the care for people living with this specific heart issue. This study is an important step in exploring new diagnostic tools to benefit patients.

Key takeaways

This study is testing a new scan for heart problems caused by cardiac sarcoidosis.
It aims to find out if the new scan is more accurate at detecting inflammatory cells in the heart.
The new scan is called 68Ga-Pentixafor PET/CT and it's compared to a standard scan.
Both men and women, aged 18 and over, may be able to join if they have or might have cardiac sarcoidosis.
The study hopes to improve how doctors diagnose and understand this heart condition.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part.

Since the study is looking at cardiac sarcoidosis, you would likely need to have been diagnosed with this condition or have doctors suspect you might have it.

The medical team will carefully check your health and medical history to make sure the study is safe for you and that you meet all the specific requirements. Always discuss your interest with your doctor.

Quick self-check

Are you 18 years old or older?
Do you have cardiac sarcoidosis, or have doctors said you might have it?
Are you able to attend appointments for imaging scans?
Have you discussed this study with your doctor?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed information for participation was not fully provided in the clinical trial summary. However, typically, participating in a study like this would involve:

* **Screening Visits:** You would have initial appointments to confirm you meet all the study requirements, which might include health checks and blood tests. * **Imaging Scans:** You would undergo the new 68Ga-Pentixafor PET/CT scan, and likely also the standard 18F-FDG PET/CT scan mentioned. * **Follow-up:** There might be follow-up appointments to monitor your health and any effects of the scans.

The total duration of your involvement could vary, from a few appointments over a short period to several months, depending on the study design. The study does not mention any specific medication you would need to take as part of the intervention, as it is focused on an imaging test. All exact details about visits, tests, and time commitment would be explained in full by the study team.

Potential risks and benefits

Potential benefits of taking part could include gaining more information about your cardiac sarcoidosis through advanced imaging. While this is a research study, the findings could ultimately lead to better diagnosis and treatment methods for future patients. Potential risks involve exposure to small amounts of radiation from the PET/CT scans, similar to other medical imaging tests. There might also be a small risk of allergic reaction to the tracer liquid used in the scans, or discomfort from injections. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is cardiac sarcoidosis?

Cardiac sarcoidosis is a condition where small clumps of inflammatory cells, called granulomas, grow in the heart muscle, which can affect its normal function.

What is 68Ga-Pentixafor PET/CT?

It's a new type of scan that uses a special liquid called a 'tracer' to help doctors see the inflammatory cells in your heart more clearly.

How is this new scan different from a standard scan?

It uses a different tracer liquid that might be better at highlighting the specific inflammatory cells linked to cardiac sarcoidosis compared to the tracer used in the standard 18F-FDG PET/CT scan.

Will I get results from the scan?

The study team will explain how and when you will receive information about your results and how these might be used for your care.

Is this a new treatment?

No, this study is testing a new way to diagnose or find cardiac sarcoidosis, not a new treatment. It's about improving how doctors see the condition.