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.

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

Study Overview

• Status: Recruiting
• Conditions: Endocarditis; Endocarditis;Chronic; Endocarditis Acute
• Intervention / Treatment: Radiation: 64Cu-DOTATATE and 18F-FDG

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.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emil L Fosbøl, MD,Ph.d.; Phone Number: 0045 3545 6340; Email: emil.fosboel@regionh.dk
• Study Contact Backup: Name: Katra Hadji-Turdeghal, MD; Phone Number: +45 3545 4885; Email: katra.hadji-turdeghal@regionh.dk

Study Locations

• Denmark
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark, 2100
      • Recruiting
      • Rigshospitalet
      • Contact: Emil L Fosbøl; Email: emil.fosboel@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A, B, C, D, E, F, G; Scans	Radiation: 64Cu-DOTATATE and 18F-FDG; All participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number(percentege) of agreement between the two scan modalities in overall population	x	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients	x	2 year

Collaborators and Investigators

• Sponsor: Emil Loldrup Fosbol
• Investigators: Principal Investigator: Emil L Fosbøl, MD,Ph.d., Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: H-21040764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The overall results of the trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No