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Clinical Trials in Denmark / NCT06392815
Recruiting Not applicable

64Cu-DOTATATE-PET for Lyme Neuroborreliosis

NCT06392815 · tracked via the Priya Life Science Denmark tracker
Sponsor
Copenhagen University Hospital, Rigshospitalet
Phase
Not applicable
Started
2024-05-20
Last updated
2024-05-21

Condition(s) studied

Borrelia Burgdorferi Neuroborreliosis

Investigational drug(s) / intervention(s)

Cu DOTATATE PET

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: Age ≥ 18 years AND * Clinical suspicion of LNB AND * Must be able to read and understand the patient information and to give informed consent - Exclusion Criteria: * Pregnancy OR * Breast-feeding OR * Concluded antibiotic treatment OR * Weight more than the maximum weight limit for the PET/CT/MRI bed of the scanner (140 kg) OR * History of allergic reaction attributable to compounds of similar chemical or biologic composition to 64Cu-DOTATATE OR * Contraindications to MR (check list) -

Primary outcome measure(s)

  • Primary — 2,5 years
    Sensitivity and specificity of 64Cu-DOTATATE PET/CT/MR for detection of LNB in patients clinically suspected of LNB using CSF as reference

Trial sites (1)

FacilityCityRegionStatus
Anne-Mette Lebech Copenhagen Capital Region Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06392815 on ClinicalTrials.gov ↗ ← All trials in Denmark