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Detecting Heart Inflammation in Cardiac Sarcoidosis Patients Using 68Ga-NOTA-Anti-MMR-VHH2 PET-CT Imaging

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying cardiac sarcoidosis, a condition where clusters of inflammatory cells form in the heart tissue. The study will use a new imaging method involving a tracer called 68Ga-NOTA-Anti-MMR-VHH2. This tracer is a special solution that is injected into the body and helps to highlight certain cells in the heart when scanned with a type of imaging called PET-CT (Positron Emission Tomography - Computed Tomography). The purpose of the study is to see if this new tracer can effectively detect areas of inflammation in the heart caused by cardiac sarcoidosis.

Participants in the study will receive an injection of the tracer 68Ga-NOTA-Anti-MMR-VHH2 and then undergo a PET-CT scan. This scan will help doctors see if there are any areas in the heart where the tracer has accumulated, indicating inflammation. The study will compare these results with previous standard imaging tests to determine the effectiveness of the new tracer. Some participants may also receive a placebo for comparison purposes.

The study will monitor participants for any side effects or reactions to the tracer. It will also compare the new imaging results with other tests to see how well the tracer works in identifying inflammation related to cardiac sarcoidosis. The study aims to improve the detection and understanding of this condition, potentially leading to better diagnosis and treatment options in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing historical diagnostic images such as an 18F-FDG PET/CT scan and a 13N-NH3 PET/CT scan, both not older than one month prior to screening.

    Eligibility criteria include being at least 18 years old and having a probable diagnosis of cardiac sarcoidosis based on specific criteria.

  2. Step 2

    Administration of tracer

    The study involves the use of a new tracer called 68Ga-NOTA-Anti-MMR-VHH2. This tracer is administered as a solution for injection through an intravenous injection.

    The purpose of this tracer is to help detect inflammation in the heart using PET-CT imaging.

  3. Step 3

    PET-CT imaging

    After the tracer is administered, a PET-CT scan is performed. This imaging technique helps visualize the presence of cardiac sarcoid lesions.

    The scan aims to detect areas with a focal or patchy uptake pattern of the tracer, which indicates sarcoid involvement.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, monitoring for any adverse events or serious adverse events is conducted.

    Follow-up assessments may include comparing the PET-CT results with other diagnostic methods to evaluate the effectiveness of the tracer in detecting cardiac sarcoidosis.

  5. Step 5

    Study completion

    The study is expected to conclude by June 30, 2026. Results will be analyzed to determine the proportion of patients with confirmed cardiac sarcoidosis based on the tracer uptake.

    The study also aims to compare the tracer's effectiveness with other imaging techniques and assess any potential development of anti-drug antibodies.

Who can join the trial?

5 criteria

  • Male and female patients who are at least 18 years old.
  • Patients with a confirmed or likely diagnosis of cardiac sarcoidosis. This means they have either a biopsy (a small tissue sample) that shows the disease or meet specific criteria from the HRS 2014 guidelines.
  • Patients must have certain past medical images available:
    • An 18F-FDG PET/CT scan, which is a type of imaging test that helps show areas of inflammation in the heart, done within 1 month before joining the study.
    • A 13N-NH3 PET/CT scan, another imaging test that helps show blood flow in the heart, also done within 1 month before joining the study.
    • Male patients who can father children and female patients who can become pregnant must agree to use effective birth control methods during the study.

Who cannot join the trial?

4 criteria

  • Patients who do not have a **probable diagnosis** of cardiac sarcoidosis based on specific criteria cannot participate. This means that if a patient does not meet the necessary conditions to be considered likely to have cardiac sarcoidosis, they are excluded.
  • Patients who are not within the specified **age range** for the study cannot participate. This means that only people of certain ages are allowed to join the study.
  • Patients who belong to a group that is not included in the study's **clinical trial groups** cannot participate. This means that only certain groups of patients are allowed to join the study.
  • Patients who are not part of the **vulnerable population** selected for the study cannot participate. This means that the study is only open to certain groups of people who may need special protection or consideration.
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Investigated drugs

68Ga-NOTA-Anti-MMR-VHH2 is a special imaging agent used in this study. It is designed to help doctors see certain types of cells, called MMR-expressing macrophages, in the heart. This imaging agent is used with a PET scan to help detect areas in the heart that might be affected by a condition called cardiac sarcoidosis. This helps doctors understand more about the disease and how it affects the heart.

What is already known about the treatment

68Ga-NOTA-Anti-MMR-VHH2 – This medication is administered through an intravenous injection and is used in a specialized imaging technique called Positron Emission Tomography (PET). It is currently being studied in clinical trials for its ability to detect cardiac sarcoidosis, a condition affecting the heart. The main therapeutic indication is to help visualize areas of inflammation in the heart by targeting specific immune cells known as macrophages. At the molecular level, it binds to a receptor on these macrophages, allowing them to be seen on PET scans. This medication falls under the pharmacological classification of radiopharmaceuticals, which are used for diagnostic imaging.

Investigated diseases

Cardiac Sarcoidosis – Cardiac sarcoidosis is a condition where clusters of inflammatory cells, known as granulomas, form in the heart tissue. This can disrupt the normal electrical signals in the heart, potentially leading to irregular heartbeats or arrhythmias. Over time, the inflammation can cause scarring and damage to the heart muscle, affecting its ability to pump blood effectively. The disease may progress with symptoms such as fatigue, shortness of breath, or chest pain. In some cases, it can lead to heart failure if the heart's function becomes significantly impaired. The exact cause of cardiac sarcoidosis is unknown, but it is believed to involve an abnormal immune response.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512473-27-00Protocol codeBW_M2-TargetEstimated enrolment15 patientsSponsorCliniques Universitaires Saint-Luc

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