64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ Age ≥ 18 years AND

• Clinical suspicion of LNB AND

• Must be able to read and understand the patient information and to give informed consent -

Locations
Other Locations
Denmark
Anne-Mette Lebech
RECRUITING
Copenhagen
Contact Information
Primary
Anne-Mette Lebech
Anne-Mette.lebech@regionh.dk
+4535458622
Time Frame
Start Date: 2024-05-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 50
Treatments
Other: Neuroborreliosis
25 patients with possible or confirmed neuroborreliosis
Other: controls
25 patients investigated for neuroborreliosis but with normal CSF examination
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark

This content was sourced from clinicaltrials.gov