64Cu-DOTATATE-PET for Lyme Neuroborreliosis
Recruiting now · Not applicable
Conditions studied: Borrelia Burgdorferi Neuroborreliosis
In brief
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.
Key facts
- Study ID
- NCT06392815
- Run by
- Rigshospitalet, Denmark
- People needed
- 50
- Starts
- 2024-05-20
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2024-05-21
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years AND
- Clinical suspicion of LNB AND
- Must be able to read and understand the patient information and to give informed consent -
You may not qualify if…
- 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) -
Where it is running
- Anne-Mette Lebech — Copenhagen, Capital Region, Denmark (enrolling)
Full record on ClinicalTrials.gov
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