Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06131112 |
| Other study ID # |
H-23035676 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2023 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
November 2023 |
| Source |
Rigshospitalet, Denmark |
| Contact |
Finn Gustafsson, MD,PhD,DMSc |
| Phone |
+45 35456340 |
| Email |
finn.gustafsson[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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)
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.
