Clinical trial Recruiting at 1 site Interventional Ages 18 to 90

Using 64Cu-DOTATATE PET imaging for diagnosing Lyme neuroborreliosis

Official title: 64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis

Run by Copenhagen University Hospital, Rigshospitalet · NCT06392815 · Data updated 2026-11-12

This study is testing a new imaging method to see if it can help doctors better diagnose Lyme neuroborreliosis in patients who might have it.

Quick facts

Study typeInterventional
Ages18 Years to 90 Years
SexAll
Enrollment50 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen, Capital Region)
StatusRecruiting
StartedMay 20, 2024
Main results expectedMarch 31, 2026
Study endsDecember 31, 2026
Registry record updatedMay 21, 2024
Trial IDNCT06392815 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who are clinically suspected of having Lyme neuroborreliosis.

Probably not a fit

Patients who are pregnant, breastfeeding, or have recently completed antibiotic treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of 64Cu-DOTATATE PET/CT/MRI imaging in diagnosing Lyme neuroborreliosis (LNB) in patients who are clinically suspected of having the condition. A total of 50 patients will be included, with comparisons made between those with confirmed LNB through cerebrospinal fluid (CSF) analysis and those without CSF verification. The researchers hypothesize that this imaging technique will enhance diagnostic accuracy and provide prognostic information regarding the risk of persistent symptoms. The ultimate goal is to improve early diagnosis and treatment initiation for better patient outcomes.

Why it matters

Potential benefit: If successful, this approach could lead to more accurate diagnoses and improved management of Lyme neuroborreliosis, potentially reducing the risk of long-term symptoms.

How similar studies have gone: While imaging for neuroinfections is established, the specific application of 64Cu-DOTATATE PET for Lyme neuroborreliosis is relatively novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion 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) -

Where it's running

  • Anne-Mette Lebech
    Copenhagen, Capital Region, Denmark
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.