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64Cu-DOTATATE-PET for Lyme Neuroborreliosis
Sponsor: Rigshospitalet, Denmark
Summary
The aim of the study is to investigate the applicability and performance of 64Cu-DOTATATE PET/CT/MR for diagnosis in patients with Lyme neuroborreliosis (LNB). In this prospective, observational cohort study with 64Cu-DOTATATE, the investigators wish to include a total of 50 patients clinically suspected of LNB. The investigators will investigate the diagnostic value of 64Cu-DOTATATE-PET comparing clinically suspected and CSF verified LNB patients with clinically suspected patients without CSF verification. The investigators hypothesize that the information obtained from 64Cu-DOTATATE PET/CT/MRI can improve the diagnostics of LNB as well as that 64Cu-DOTATATE PET/CT/MRI will be able to contribute to the follow-up of patients by adding prognostic information and the risk of persistent symptoms. The application of 64Cu-DOTATATE PET/CT/MRI in the diagnostic work-up of LNB would thus expectedly lead to a more precise diagnosis and risk assessment.
Official title: 64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-05-20
Completion Date
2026-12-31
Last Updated
2024-05-21
Healthy Volunteers
No
Conditions
Interventions
Cu DOTATATE PET
The primary endpoint of the study is diagnostic performance for detecting LNB by 64Cu-DOTATATE-PET/CT/MRI measured as the difference in uptake between patients with definite LNB and patients without LNB. The primary read-out from 64Cu-DOTATATE-PET/CT/MRI is SUV in CNS and reference organs
Locations (1)
Anne-Mette Lebech
Copenhagen, Capital Region, Denmark