Actively Recruiting
64Cu-DOTATATE-PET for Lyme Neuroborreliosis
Led by Rigshospitalet, Denmark · Updated on 2024-05-21
50
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
64Cu-DOTATATE-PET for Lyme Neuroborreliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical suspicion of Lyme neuroborreliosis
- Able to read, understand patient information, and give informed consent
You will not qualify if you...
- Pregnancy
- Breastfeeding
- Completed antibiotic treatment for Lyme neuroborreliosis
- Weight exceeding 140 kg (scanner bed limit)
- History of allergic reaction to compounds similar to 64Cu-DOTATATE
- Contraindications to MRI (per checklist)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Anne-Mette Lebech
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
A
Anne-Mette Lebech
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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