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Search / Trial NCT06131112

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

Launched by RIGSHOSPITALET, DENMARK · Nov 8, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The CuDOSIS study is a clinical trial designed to improve the diagnosis of cardiac sarcoidosis, a condition where inflammation affects the heart. Researchers are using a special imaging technique called PET/CT with a tracer named 64Cu-DOTATATE to identify activated immune cells known as macrophages in the heart. The study aims to include 54 participants, including patients who are suspected of having cardiac sarcoidosis or already have it, as well as patients with a different heart condition called acute lymphocytic myocarditis and some who had previous scans for a different condition.

To participate in this trial, individuals must be at least 18 years old and fall into one of the specified groups, such as those suspected of having cardiac sarcoidosis or those with previously scanned neuroendocrine tumors. However, certain conditions will exclude potential participants, like severe obesity, pregnancy, or significant anxiety about being in confined spaces. Participants can expect to undergo the PET/CT imaging procedure, which is non-invasive and helps doctors better understand their heart health. The study is currently recruiting, and it’s a great opportunity for those looking to contribute to medical research while seeking answers about their condition.

Gender

ALL

Eligibility 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

About Rigshospitalet, Denmark

Rigshospitalet, located in Copenhagen, Denmark, is one of the leading hospitals in Scandinavia and a prominent center for clinical research and innovation. As a key academic institution affiliated with the University of Copenhagen, Rigshospitalet is dedicated to advancing healthcare through rigorous clinical trials and groundbreaking research across various medical disciplines. The hospital’s commitment to excellence is reflected in its multidisciplinary approach, collaboration with international research networks, and focus on improving patient outcomes through evidence-based practices. With state-of-the-art facilities and a team of highly qualified professionals, Rigshospitalet plays a crucial role in translating scientific discoveries into effective treatments and therapies.

Locations

Copenhagen, , Denmark

Patients applied

0 patients applied

Trial Officials

Finn Gustafsson, MD,PhD,DMSc

Principal Investigator

Rigshospitalet, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported