Clinical Trials Logo

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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06131112
Study type Observational
Source Rigshospitalet, Denmark
Contact Finn Gustafsson, MD,PhD,DMSc
Phone +45 35456340
Email finn.gustafsson@regionh.dk
Status Recruiting
Phase
Start date November 1, 2023
Completion date January 2027

See also
  Status Clinical Trial Phase
Completed NCT03705884 - PET/MR Imaging In Patients With Cardiac Sarcoidosis N/A
Recruiting NCT04017936 - Interleukin-1 Blockade for Treatment of Cardiac Sarcoidosis Phase 2
Terminated NCT03923049 - Feasibility and Accuracy of Hybrid Magnetic Resonance and Positron Emission Tomography With 18F-Fluorodeoxyglucose in Diagnosing Cardiac Sarcoidosis N/A
Not yet recruiting NCT05954507 - Evaluation of the Prognostic Value of PET/MRI in Cardiac Sarcoidosis N/A
Recruiting NCT04737317 - Diagnostic Criteria in Cardiac Sarcoidosis
Recruiting NCT06409585 - Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Recruiting NCT03057002 - UTSW HP [13-C] Pyruvate Injection in HCM
Completed NCT03599414 - CASPA: CArdiac Sarcoidosis in PApworth
Withdrawn NCT02812849 - Somatostatin Receptor Imaging in Cardiac Sarcoidosis
Completed NCT01729169 - Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET N/A
Completed NCT03549598 - d68Ga-DOTATATE PET/CT Assessment of Cardiac Sarcoidosis Phase 4
Recruiting NCT04758650 - Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions, Cardiovascular Atherosclerosis, Syndrome With Abnormal Immune Activation and sarcoïdosis Phase 2
Recruiting NCT04206163 - Somatostatin Receptor Imaging in Acute Myocarditis and Cardiac Sarcoidosis N/A
Recruiting NCT05499637 - [68Ga]Ga-PentixaFor PET/CT in Acute Myocardial Inflammation Phase 2
Recruiting NCT03593759 - Cardiac Sarcoidosis Randomized Trial Phase 3
Recruiting NCT05145023 - Development and Validation of a Health-related Quality of Life Tool for Patients With Cardiac Sarcoidosis
Enrolling by invitation NCT04774549 - Inflammatory Cardiomyopathy Bern Registry
Recruiting NCT03049254 - Mayo AVC Registry and Biobank
Completed NCT03746847 - PET Imaging in Patients With Suspected Cardiac Sarcoidosis
Recruiting NCT01477359 - Cardiac Sarcoidosis Multi-Center Prospective Cohort