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

NCT06131112 | Recruiting

• 1 other identifier: H-23035676
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Cardiac Sarcoidosis

Outcome Measures

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).

  2 years

Secondary Outcomes (3)

• 24-month rates of adverse outcomes

  2 years

• Tracer uptake - myocarditis

  2 years

• Distribution of tracer uptake

  2 years

Study Arms (4)

Group A

22 patients with clinically suspected cardiac sarcoidosis

Diagnostic Test: 64Cu-DOTATATE PET/CT scan

Group B

22 patients with known cardiac sarcoidosis

Diagnostic Test: 64Cu-DOTATATE PET/CT scan

Group C

Up to 10 patients with clinically suspected or confirmed acute lymphocytic myocarditis

Diagnostic Test: 64Cu-DOTATATE PET/CT scan

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)

Interventions

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.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Study Officials

• Finn Gustafsson, MD,PhD,DMSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Finn Gustafsson, MD,PhD,DMSc

CONTACT

+45 35456340; finn.gustafsson@regionh.dk

Adelina Yafasova, MD

CONTACT

+45 35456252; adelina.henney.yafasova@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: November 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)