NCT06392815 64Cu-DOTATATE-PET for Lyme Neuroborreliosis
| NCT ID | NCT06392815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Borrelia Burgdorferi Neuroborreliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-05-20 with a primary completion date of 2026-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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) -
Contact & Investigator
Anne-Mette Lebech
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT06392815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Borrelia Burgdorferi Neuroborreliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06392815 currently recruiting?
Yes, NCT06392815 is actively recruiting participants. Contact the research team at Anne-Mette.lebech@regionh.dk for enrollment information.
Where is the NCT06392815 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06392815 clinical trial?
NCT06392815 is sponsored by Rigshospitalet, Denmark. The principal investigator is Anne-Mette Lebech at Rigshospitalet, Denmark. The trial plans to enroll 50 participants.