Actively Recruiting
64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis
Led by Rigshospitalet, Denmark · Updated on 2024-05-21
50
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of 64Cu-DOTATATE PET/CT/MRI imaging to improve diagnosis and monitoring of Lyme neuroborreliosis (LNB), a tick-borne infection affecting the nervous system. This study aims to compare patients clinically suspected and cerebrospinal fluid (CSF) verified with LNB against those suspected without CSF verification. The goal is to see if this imaging technique can provide more precise diagnosis, prognostic information, and risk assessment for lingering symptoms after treatment. The study involves 50 patients divided into two groups: 25 with possible or confirmed neuroborreliosis and 25 investigated but with normal CSF results. Participants will undergo 64Cu-DOTATATE PET/CT/MRI scans, which target activated macrophages involved in infection. This non-invasive imaging method is being assessed for its diagnostic value and ability to support follow-up six months after treatment, alongside blood biomarker testing including sCD163, NfL, and Tau. During the study, participants will have PET/CT/MRI scans to measure tracer uptake in the central nervous system and reference organs. Clinical symptoms, laboratory markers, and imaging results will be tracked to evaluate disease activity and prognosis. The primary outcomes focus on diagnostic performance over 2.5 years, with secondary measures also assessed. The study monitors patients without interventions beyond imaging and biomarker collection, lasting from initial evaluation through follow-up visits.
CONDITIONS
Brief 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 and understand patient information and provide 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 as per checklist
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo 64Cu-DOTATATE-PET/CT/MRI imaging to help diagnose Lyme neuroborreliosis and assess disease activity.
1 imaging visit (in-person)
Duration - 6 months post-treatment
Participants are followed up 6 months after treatment to evaluate symptoms and the prognostic value of imaging and biomarkers.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Anne-Mette Lebech
Copenhagen, Capital Region, Denmark, 2100
Actively Recruiting
Research Team
A
Anne-Mette Lebech
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here