EndocarditisNCT05432427
64Cu-DOTATATE PET-CT-skanning and Infective Endocarditis.
A study testing 64Cu-DOTATATE and 18F-FDG in people with Endocarditis and Endocarditis;Chronic, run by Emil Loldrup Fosbol at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endocarditis, Endocarditis;Chronic, Endocarditis Acute
- What is being tested?
- 64Cu-DOTATATE and 18F-FDG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Apr 2022to 29 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Endocarditis, Endocarditis;Chronic, Endocarditis Acute
- Being tested
- 64Cu-DOTATATE and 18F-FDG
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
64Cu-DOTATATE and 18F-FDGRadiation
All participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT.
| Study group | Role | What they receive |
|---|---|---|
| Group A, B, C, D, E, F, G | Experimental | Scans Receives: Radiation: 64Cu-DOTATATE and 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number(percentege) of agreement between the two scan modalities in overall population
x
Measured: 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
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start28 Apr 2022
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndocarditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Controlled prospectiv cohort study. Patients in the trial get a 64Cu-DOTATATEPET/ CT and/or 18F-FDG-PET/CT
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emil Loldrup Fosbol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emil Loldrup Fosbol, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Emil L Fosbøl, MD,Ph.d., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05432427
- Sponsor's protocol ID
- H-21040764
- Status last verified
- Jun 2022
- First submitted
- 15 Jun 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The overall results of the trial
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 64Cu-DOTATATE PET-CT-skanning to Diagnose Macrophage Infiltration in the Heart Valves of Patients with Infective Endocarditis.
- ClinicalTrials.gov ID
- NCT05432427
- Acronym / sponsor ID
- H-21040764
- Conditions
- Endocarditis, Endocarditis;Chronic, Endocarditis Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Emil Loldrup FosbolUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Controlled prospectiv cohort study. Patients in the trial get a 64Cu-DOTATATEPET/ CT and/or 18F-FDG-PET/CT
| Arm | Type | Receives |
|---|---|---|
| Group A, B, C, D, E, F, G | Experimental | Radiation: 64Cu-DOTATATE and 18F-FDGScans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 64Cu-DOTATATE and 18F-FDGAll participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT. | Radiation | Group A, B, C, D, E, F, G |
Primary outcome
The number(percentege) of agreement between the two scan modalities in overall population
Time frame: 2 year
x
1 secondary outcome
Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients
Time frame: 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No. The overall results of the trial
Related trials for Endocarditis
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Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Not yet recruitingObservational study
REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emil L Fosbøl, MD,Ph.d. principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 64Cu-DOTATATE and 18F-FDG in people with Endocarditis and Endocarditis;Chronic, run by Emil Loldrup Fosbol at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number(percentege) of agreement between the two scan modalities in overall population (time frame: 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.