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64Cu-DOTATATE-PET for Lyme Neuroborreliosis

NCT06392815 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Borrelia Burgdorferi Neuroborreliosis

Interventions

DIAGNOSTIC_TEST

Cu DOTATATE PET

The primary endpoint of the study is diagnostic performance for detecting LNB by 64Cu-DOTATATE-PET/CT/MRI measured as the difference in uptake between patients with definite LNB and patients without LNB. The primary read-out from 64Cu-DOTATATE-PET/CT/MRI is SUV in CNS and reference organs

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Anne-Mette Lebech · Rigshospitalet, Denmark

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06392815 on ClinicalTrials.gov