Using 64Cu-DOTATATE PET imaging for diagnosing Lyme neuroborreliosis
64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis
NA · Rigshospitalet, Denmark · NCT06392815
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT06392815 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are clinically suspected of having Lyme neuroborreliosis.
Not a fit: Patients who are pregnant, breastfeeding, or have recently completed antibiotic treatment may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Copenhagen, Capital Region
- Anne-Mette Lebech — Copenhagen, Capital Region, Denmark (RECRUITING)
Study contacts
- Principal investigator: Anne-Mette Lebech — Rigshospitalet, Denmark
- Study coordinator: Anne-Mette Lebech
- Email: Anne-Mette.lebech@regionh.dk
- Phone: +4535458622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Borrelia Burgdorferi Neuroborreliosis, borrelia burgdorferi, Neuroborreliosis, Dotatate PET