search
Back to results

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

Primary Purpose

Endocarditis, Endocarditis;Chronic, Endocarditis Acute

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
64Cu-DOTATATE and 18F-FDG
Sponsored by
Emil Loldrup Fosbol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Endocarditis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Scans

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2022
Last Updated
June 20, 2022
Sponsor
Emil Loldrup Fosbol
search

1. Study Identification

Unique Protocol Identification Number
NCT05432427
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emil Loldrup Fosbol

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endocarditis, Endocarditis;Chronic, Endocarditis Acute

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A, B, C, D, E, F, G
Arm Type
Experimental
Arm Description
Scans
Intervention Type
Radiation
Intervention Name(s)
64Cu-DOTATATE and 18F-FDG
Intervention Description
All participants will get a 64Cu-DOTATATE-PET and 18F-FDG-PET/CT.
Primary Outcome Measure Information:
Title
The number(percentege) of agreement between the two scan modalities in overall population
Description
x
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Compare the number of agreement in the uptake between the two scan modalities in infected patients versus newly operated patients
Description
x
Time Frame
2 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emil L Fosbøl, MD,Ph.d.
Phone
0045 3545 6340
Email
emil.fosboel@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Katra Hadji-Turdeghal, MD
Phone
+45 3545 4885
Email
katra.hadji-turdeghal@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emil L Fosbøl, MD,Ph.d.
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Region Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emil L Fosbøl
Email
emil.fosboel@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The overall results of the trial

Learn more about this trial

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

We'll reach out to this number within 24 hrs