What is 64Cu-DOTATATE PET studying for Lyme neuroborreliosis?

64Cu-DOTATATE PET is being studied as a new imaging method to improve diagnosis and follow-up of Lyme neuroborreliosis, a nervous system infection. Researchers aim to see if this scan can better detect active infection and predict persistent symptoms. The study is led by Rigshospitalet in Denmark.

Who may be eligible for this Lyme neuroborreliosis clinical trial?

Adults aged 18 to 90 years with clinical suspicion of Lyme neuroborreliosis may be eligible. The trial accepts all genders and excludes those who are pregnant, breastfeeding, have completed antibiotic treatment, or exceed weight limits for the imaging scanner. Please review eligibility criteria for more details.

Is there any cost to participate in this Lyme neuroborreliosis clinical trial?

Study-related care, including the imaging scans and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect all study tests and visits to be free of charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 90Years

All Genders

ID06392815

Using 64Cu-DOTATATE PETCTMRI for Diagnosing and Following Lyme Neuroborreliosis in Adults

Led by Rigshospitalet, Denmark · Updated on 2024-05-21

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of 64Cu-DOTATATE PETCTMRI imaging to improve diagnosis and monitoring of Lyme neuroborreliosis LNB, a tick-borne infection affecting the nervous system. This study aims to compare patients clinically suspected and cerebrospinal fluid CSF verified with LNB against those suspected without CSF verification. The goal is to see if this imaging technique can provide more precise diagnosis, prognostic information, and risk assessment for lingering symptoms after treatment. The study involves 50 patients divided into two groups 25 with possible or confirmed neuroborreliosis and 25 investigated but with normal CSF results. Participants will undergo 64Cu-DOTATATE PETCTMRI scans, which target activated macrophages involved in infection. This non-invasive imaging method is being assessed for its diagnostic value and ability to support follow-up six months after treatment, alongside blood biomarker testing including sCD163, NfL, and Tau. During the study, participants will have PETCTMRI scans to measure tracer uptake in the central nervous system and reference organs. Clinical symptoms, laboratory markers, and imaging results will be tracked to evaluate disease activity and prognosis. The primary outcomes focus on diagnostic performance over 2.5 years, with secondary measures also assessed. The study monitors patients without interventions beyond imaging and biomarker collection, lasting from initial evaluation through follow-up visits.

CONDITIONS

Brief Title

64Cu-DOTATATE-PET for Lyme Neuroborreliosis

Who Can Participate

Age: 18Years - 90Years

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Clinical suspicion of Lyme neuroborreliosis
Able to read and understand patient information and provide informed consent

You will not qualify if you...

Pregnancy
Breastfeeding
Completed antibiotic treatment for Lyme neuroborreliosis
Weight exceeding 140 kg (scanner bed limit)
History of allergic reaction to compounds similar to 64Cu-DOTATATE
Contraindications to MRI as per checklist

Research Team

Anne-Mette Lebech

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