NCT05432427

64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.

64Cu-DOTATATE PET-CT-skanning to Diagnose Macrophage Infiltration in the Heart Valves of Patients with Infective Endocarditis.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Emil Loldrup Fosbol · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesize that the 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis - thus increasing the sensitivity and specificity compared to 18F-FDG PET/CT

Detailed description

Infective endocarditis (IE) is an infection of the heart lining, primarily mediated by an endothelial injury causing activation of inflammatory cytokines and cells thus forming a thrombus creating a basis for bacteria adherence. The incidence rate is estimated to 2-10 cases per 100.000 people. In hospital mortality rates have been reported to 14-30%. Hence,it is therefore also worrisome that the incidence of IE has significantly increased in the adult population the last decades. Several reasons for this incline in incidence have been suggested: an increasing elderly population, an increase in the prevalence of prosthetic heart valves and cardiac electronic devices and better diagnostics technique. Prosthetic valve endocarditis (PVE) is uncommon but severe complication to surgical and transcatheter valve replacement. Early studies have estimated PVE to account for up to 5% of all IE cases, however in recent studies PVE represents an increased proportion of overall infective endocarditis cases -estimated for almost 20%. Staphylococcus aureus is the most common cause of PVE. The mortality rate of PVE patients is significantly higher than native valve endocarditis (NVE) - in hospital mortality is estimated from 22% to 42% for PVE, and one year mortality for PVE is estimated to 21%-80%. The PVE diagnosis is often hard to verify as the symptoms of IE vary broadly.18Fflurodeoxyglukocose positron emission tomography/computed tomography (18F-FDGPET/ CT) is recommended as diagnostic imaging technique, however the sensitivity is 83.5% and specificity is 70.8%. The aim of this trial is to investigate whether 64Cu-DOTATATE will show uptake in the infected vegetations on the prosthetic heart valves and increase the accuracy of the right diagnosis.

Conditions

• Endocarditis
• Endocarditis;Chronic
• Endocarditis Acute

Interventions

Type	Name	Description
RADIATION	64Cu-DOTATATE and 18F-FDG	All participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT.

Timeline

• Start date: 2022-04-28
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2022-06-27
• Last updated: 2024-12-27

Locations

1 site across 1 country: Denmark