Infective endocarditis MedDRA version: 20.0 Level: LLT Classification code 10014688 Term: Endocarditis, valve unspecified System Organ Class: 100000004862
Conditions
Interventions
Product Name: 64Cu-DOTATATE
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: 64Cu-DOTATATE
Other descriptive name: DOTATATE
Concentration unit: µg microgram
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Inclusion 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. 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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 6 monts (group D-F);Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Countries
Denmark
Contacts
Public ContactDepartment of Cardiology
Rigshospitalet
Outcome results
None listed