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RecruitingNot ApplicableNCT06392815

64Cu-DOTATATE-PET for Lyme Neuroborreliosis

64Cu-DOTATATE-PET Imaging for Lyme Neuroborreliosis

Sponsor

Rigshospitalet, Denmark

Enrollment

50 participants

Start Date

May 20, 2024

Study Type

INTERVENTIONAL

Conditions

Borrelia Burgdorferi Neuroborreliosis

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

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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) -
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Interventions

DIAGNOSTIC_TESTCu 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

Locations(1)

Anne-Mette Lebech

Copenhagen, Capital Region, Denmark

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NCT06392815