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A Study Testing the Accuracy of 68Ga-Pentixafor PET/CT Imaging in Patients with Cardiac Sarcoidosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at cardiac sarcoidosis, which is a condition where small collections of inflammatory cells form in the heart muscle. Sarcoidosis is a disease that can affect different parts of the body, and when it involves the heart, it can cause problems with how the heart works. The study will use a substance called [68Ga]Ga-PentixaFor, which is given as an injection into a vein. This substance contains gallium-68 and pentixafor, and it is used together with a special imaging test called positron emission tomography combined with computed tomography, or PET/CT for short. This imaging method creates detailed pictures of the inside of the body and can help doctors see areas of inflammation in the heart.

The purpose of the study is to check how well 68Ga-Pentixafor PET/CT can detect cardiac sarcoidosis. The results from this new scan will be compared to another scan called 18F-FDG PET/CT, which is already used in regular medical practice to look for this condition. The study will involve patients who have sarcoidosis in other parts of their body and who are suspected of having or already have cardiac sarcoidosis. These patients will receive the 68Ga-Pentixafor injection and undergo the PET/CT scan in addition to their regular 18F-FDG scan.

During the study, doctors will look at the scan images to see if and where the 68Ga-Pentixafor is taken up in the heart muscle. They will measure how much of the substance appears in different areas and describe the pattern of uptake, whether it appears in small spots or spread throughout the heart. The images will be examined by experienced doctors who will compare their findings. The study will also check if the substance shows up in other organs that might be affected by sarcoidosis and will look at how the substance moves through the body over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial imaging scan with standard tracer

    You will undergo a PET/CT scan (a type of imaging that combines two scanning techniques to create detailed pictures of the inside of your body) using a standard tracer called 18F-FDG. This scan is part of your regular medical care and has already been planned by your doctor to examine your heart for possible sarcoidosis (an inflammatory condition).

    This scan serves as the reference test in the study.

  2. Step 2

    Additional imaging scan with study medication

    You will receive an additional PET/CT scan using a different tracer called [68Ga]Ga-PentixaFor. This is the investigational product being tested in this study.

    The medication [68Ga]Ga-PentixaFor is a solution that will be given to you through a vein in your arm (intravenous administration). The specific dose and timing will be determined by the study doctor.

    This scan is performed to evaluate how accurately this new tracer can detect cardiac sarcoidosis compared to the standard scan.

  3. Step 3

    Image analysis

    After your scans are completed, specialized doctors will analyze the images from both scans.

    The images will be examined for the presence, pattern, location, and intensity of any uptake of the tracers in your heart muscle and other organs.

    The analysis will include measurements of how much tracer accumulates in different areas and will compare the results from both scanning methods.

Who can join the trial?

4 criteria

  • You must be an adult, which means you need to be 18 years old or older
  • You must have a confirmed diagnosis of extracardiac sarcoidosis, which means sarcoidosis affecting parts of your body outside the heart
  • You must have suspected or possible cardiac sarcoidosis, which is sarcoidosis that may be affecting your heart
  • You must be scheduled to have a 18F-FDG PET/CT scan as part of your regular medical care. This is a special imaging test that uses a small amount of radioactive sugar to take detailed pictures of your heart and help doctors see if there is inflammation or disease

Who cannot join the trial?

1 criterion

  • The study information does not list specific reasons why patients cannot participate in this clinical trial.
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Investigated drugs

68Ga-Pentixafor is a radioactive tracer used during a special imaging scan called PET/CT. This medication helps doctors take detailed pictures of the heart to look for signs of cardiac sarcoidosis, which is a condition where inflammation occurs in the heart tissue. The tracer is injected into the body and travels to areas of inflammation, making them visible on the scan so doctors can better diagnose and understand the condition.

What is already known about the treatment

68Ga-Pentixafor – This is a radioactive imaging agent administered intravenously that is currently being studied in clinical trials for its potential use in diagnosing cardiac sarcoidosis, a condition where inflammatory cells form abnormal clumps in the heart tissue. The medication works by attaching to specific proteins called CXCR4 receptors that are present on inflammatory cells, allowing doctors to see areas of inflammation in the heart when used with a special scanning technique called PET/CT imaging. It belongs to the class of radiopharmaceutical diagnostic agents, which are substances that help create detailed images of what is happening inside the body at a molecular level.

Investigated diseases

Cardiac Sarcoidosis – Cardiac sarcoidosis is a condition where abnormal clusters of inflammatory cells, called granulomas, form in the heart tissue. These granulomas can develop in various parts of the heart, including the heart muscle, the electrical pathways that control heartbeat, and the outer lining of the heart. As the disease progresses, these inflammatory clusters can interfere with the heart's normal function. The inflammation may affect how the heart pumps blood and how electrical signals travel through the heart. Over time, the granulomas can lead to scarring of the heart tissue, which may cause irregular heartbeats or affect the heart's ability to pump effectively. This condition is part of a broader disease called sarcoidosis, which can affect multiple organs in the body, but in this form specifically involves the heart.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523646-27-00Protocol codeASPECT-001Estimated enrolment20 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

sourced from the EU Clinical Trials Register and site verification

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