About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

The study will include adults (18 years or older) from the Department of Cardiology and Department of Clinical Physiology, Nuclear Medicine, and PET at Rigshospitalet. The study will include a total of 76 participants: 54 patients from groups A-C and data from 22 patients from group D.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

64Cu-DOTATATE PET/CT scan
Diagnostic test
Patients in group A-C will have a 64Cu-DOTATATE PET/CT scan performed in addition to routine clinical procedures. Group D has had 64Cu-DOTATATE PET/CT performed as part of their clinical diagnostic work-up or follow-up; these data are retrospectively identified and included in the study, and group D will not be subject to any scans in the study.

Treatment groups

76 Participants

are divided into 4 treatment groups

Group A: Group A1 intervention

Group B: Group B1 intervention

Group C: Group C1 intervention

Group D: Group D0 interventions

Trial outcomes

Primary outcomes

1

Tracer uptake - cardiac sarcoidosis and neuroendocrine tumor (negative control)

The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified cardiac sarcoidosis and the proportion of patients without tracer uptake in the heart on 64Cu-DOTATATE PET/CT for patients with a neuroendocrine tumor without a history of inflammatory heart disease (the control group).

Time frame

2 years

Secondary outcomes

1

24-month rates of adverse outcomes

Death, heart failure hospitalizations, decrease of left ventricular ejection fraction to \<10% and \<50%, new-onset ventricular tachycardia, new-onset atrioventricular block, implantable cardioverter-defibrillator implantation, shocks from implantable cardioverter-defibrillator, pacemaker implantation, cardiac resyncronization therapy

Time frame

2 years

2

Tracer uptake - myocarditis

The proportion of patients with tracer uptake in the heart on 64Cu-DOTATATE PET/CT in patients with verified acute lymphocytic myocarditis

Time frame

2 years

3

Distribution of tracer uptake

The distribution of tracer uptake in the heart in patients with cardiac sarcoidosis and acute lymphocytic myocarditis, respectively

Time frame

2 years

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts