Clinical trial NCT05432427: 64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.
Official title: 64Cu-DOTATATE PET-CT-skanning to Diagnose Macrophage Infiltration in the Heart Valves of Patients with Infective Endocarditis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endocarditis
Endocarditis;Chronic
Endocarditis Acute
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Controlled prospectiv cohort study. Patients in the trial get a 64Cu-DOTATATEPET/ CT and/or 18F-FDG-PET/CT
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Be able to understand given information and sign informered consent
* Group A: native heart valves without clinical or paraclinical sign of infection
* Group B: native heart valves with verified endocarditis (according to modified Duke-criteria)
* Group C: prothethic heart valves(mechanical or biological) without clinical or paraclinical sign of infection and more \>1 year sind the heart operation
* Group D: infected prothethic heart valves, in addition clinical and paraclinical signs of infection (blood cultures and samples) and echocardiography
* Group E: newly operated in the heart valves without infection (6 months since operation)
* Group F: newly heart valve operation due to endocarditis (6 monts since operation)
* Group G: chronical infection in the aortic valce - lifelong antibiotics.

Exclusion Criteria:

* allergi for 64Cu-DOTATATE or 18-FDG
* obesity(weight over 140 kg)
* critically ill, and PET scan not possible
* Pregnancy or suspected pregnancy - negativ hCG will be required for fertile women
* severe claustrophobia
* diabetes - defined by farmacological treatment
* recent heart operation(\<4 weeks)

Primary outcomes:
measure: The number(percentege) of agreement between the two scan modalities in overall population
timeFrame: 2 year
Secondary outcomes:
measure: Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients
timeFrame: 2 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Region Hovedstaden
Study officials:
affiliation: Rigshospitalet, Denmark
name: Emil L Fosbøl, MD,Ph.d.
role: PRINCIPAL_INVESTIGATOR
References: