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CompletedNCT05432427Updated Dec 27, 2024

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

An interventional study of 64Cu-DOTATATE and 18F-FDG in Endocarditis, Endocarditis;Chronic and Endocarditis Acute, sponsored by Emil Loldrup Fosbol. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-27.

Sponsored by Emil Loldrup Fosbol · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Endocarditis
  • Endocarditis;Chronic
  • Endocarditis Acute

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03

In context

Endocarditis

173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.

This study's enrollment of 69 is below the median of 92 across 86 interventional studies indexed under Endocarditis.

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Lead sponsor

Emil Loldrup Fosbol is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Experimental
    Group A, B, C, D, E, F, G

    Scans

    Radiation: 64Cu-DOTATATE and 18F-FDG

Interventions

  • Radiation64Cu-DOTATATE and 18F-FDG

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

06

What researchers measure

Primary outcomes

  1. The number(percentege) of agreement between the two scan modalities in overall population

    x

    Time frame: 2 year

Secondary outcomes

  1. Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients

    x

    Time frame: 2 year

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Region Hovedstaden 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No — The overall results of the trial

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05432427
Lead sponsor
Emil Loldrup Fosbol
Responsible party
Emil Loldrup Fosbol (Chief Physician, ph.d., Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Jun 27, 2022
Start date
Apr 28, 2022
Primary completion
Sep 29, 2023
Completion
Sep 29, 2023
Last update
Dec 27, 2024

Study contacts

Emil L Fosbøl, MD,Ph.d.
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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