64Cu-DOTATATE PET/CT-skanning to diagnose infection in the heart valves

Phase 1

• Conditions: Infective endocarditis; MedDRA version: 20.0Level: LLTClassification code 10014688Term: Endocarditis, valve unspecifiedSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005501-27-DK
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-14
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 65

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: We 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;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint of this trial is the procentage with higher tracer up-take of 64Cu-DOTATATE-PET og 18F-FDG-PET/CT compared to the clinical diagnosis. And opposite the percentage without tracer up-take that clinically were suspected to have infective endocarditis.;Timepoint(s) of evaluation of this end point: After scan of 15 patiens with verified infective endocarditis.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Compare the uptake of 64Cu-DOTATETE and 18F-FDG in the heart valves in infected patients versus newly operated patients at inclusion and after<br>6 monts (group D-F);Timepoint(s) of evaluation of this end point: At the end of the trial