Imaging activated macrophages in cardiac sarcoidosis using 64Cu-DOTATATE

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the diagnostic effectiveness of 64Cu-DOTATATE PET/CT imaging for identifying activated macrophages in patients suspected of having cardiac sarcoidosis. It is an open-label, prospective observational study involving 54 participants, including those with clinically suspected or confirmed cardiac sarcoidosis and a control group of patients with neuroendocrine tumors. The study seeks to improve upon the limitations of the current diagnostic method, 18F-FDG PET/CT, by using a tracer that requires less patient preparation and minimizes adverse effects. Participants will undergo PET/CT scans to assess the presence of macrophage infiltration in the heart.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age =\> 18 years
* Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22 patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NET without known inflammatory heart disease who have previously been scanned with 64Cu-DOTATATE PET/CT as part of their routine diagnostic work-up or follow-up (control group)

Exclusion Criteria:

* Severe obesity (weight \> 140 kg)
* Pregnancy (negative point-of-care urine/serum human chorion gonadotropin is required in all fertile women)
* Severe claustrophobia
* Known allergy to 64Cu-DOTATATE
* Clinically critical condition which makes PET/CT impossible
* Diabetes with insulin dependence

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Principal investigator: Finn Gustafsson, MD,PhD,DMSc — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Finn Gustafsson, MD,PhD,DMSc
• Email: finn.gustafsson@regionh.dk
• Phone: +45 35456340

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.