Macrophage PET/CT Imaging Using 64Cu-DOTATATE for the Diagnosis of Cardiac Sarcoidosis

Last updated: November 8, 2023
Sponsor: Rigshospitalet, Denmark
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcoidosis

Treatment

64Cu-DOTATATE PET/CT scan

Clinical Study ID

NCT06131112
H-23035676
  • Ages > 18
  • All Genders

Study Summary

The purpose of the CuDOSIS study is to examine the diagnostic value of activated macrophage imaging in patients with or under evaluation for cardiac sarcoidosis. The PET/CT tracer 64Cu-DOTATATE is used as a tool to identify activated macrophages. The trial is an open-label prospective study. The study will include 54 participants from the Department of Cardiology and the Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. Further, the study will include data from 22 patients with NET who have been scanned with 64Cu-DOTATATE PET/CT previously as negative controls.

Participants will be included in the following groups:

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age => 18 years
  • Group A: 22 patients with clinically suspected cardiac sarcoidosis Group B: 22patients with known cardiac sarcoidosis Group C: Up to 10 patients with clinicallysuspected or confirmed acute lymphocytic myocarditis Group D: 22 patients with NETwithout 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 (controlgroup)

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 76
Treatment Group(s): 1
Primary Treatment: 64Cu-DOTATATE PET/CT scan
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
January 31, 2027

Study Description

Cardiac involvement is considered a serious condition and a frequent cause of death in patients with sarcoidosis. 18F-FDG PET/CT is currently used as part of the diagnostic criteria for cardiac sarcoidosis, but it has shown limitations in the evaluation of cardiac sarcoidosis due to the high physiological uptake of FDG in normal cardiac muscle. Elaborate preparations are required for patients including either a low-carbohydrate diet followed by long fasting or heparin loading before FDG-PET. In heparin loading, the rare adverse effect of heparin-induced thrombocytopenia should be considered. Therefore, it is of interest to find a PET/CT tracer that displays high sensitivity and specificity without requiring thorough patient preparation and minimizing any adverse effects.

A potential tracer is the somatostatin-based tracer 64Cu-DOTATATE, which is routinely used for the diagnosis and monitoring of treatment response in patients with neuroendocrine tumors. Inflammatory cells, including macrophages that are found in sarcoid granulomas, express somatostatin receptors on their surface, whereas normal cardiomyocytes do not. This allows for the potential use of macrophage imaging in cardiac sarcoidosis.

In the CuDOSIS trial, groups A and B (suspected and confirmed cardiac sarcoidosis, respectively) will be scanned with 64Cu-DOTATATE PET/CT in addition to the routinely performed 18F-FDG PET/CT. Further, to examine whether the macrophage infiltration pattern is different in patients with cardiac sarcoidosis and other inflammatory heart diseases, a group of patients with confirmed or clinically suspected myocarditis will be included (group C); this group will only be scanned with 64Cu-DOTATATE PET/CT. Finally, data from a group of patients with neuroendocrine tumours (negative controls) who have previously been scanned with 64Cu-DOTATATE will be included.

Connect with a study center

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.