Imaging activated macrophages in cardiac sarcoidosis using 64Cu-DOTATATE
Macrophage PET/CT Imaging for the Diagnosis of Cardiac Sarcoidosis
This study is testing a new type of PET/CT scan using a special tracer to see if it can better identify heart inflammation caused by sarcoidosis in patients who may have the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 76 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06131112 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with clinically suspected or confirmed cardiac sarcoidosis, acute lymphocytic myocarditis, or neuroendocrine tumors without inflammatory heart disease.
Not a fit: Patients with severe obesity, pregnancy, severe claustrophobia, known allergies to 64Cu-DOTATATE, or clinically critical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and less invasive diagnosis of cardiac sarcoidosis.
How similar studies have performed: While the use of 64Cu-DOTATATE for this specific purpose is novel, similar imaging approaches have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Finn Gustafsson, MD,PhD,DMSc — Rigshospitalet, Denmark
- Study coordinator: Finn Gustafsson, MD,PhD,DMSc
- Email: finn.gustafsson@regionh.dk
- Phone: +45 35456340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.