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Recruiting NCT07685873

Monoamine Oxidase B PET/CT in Various MAO-B-Related Disease

Observational Parkinson Disease Parkinson Disease Dementia Parkinson's Disease and Parkinsonism

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diagnostic Test: 18F-FPyCO/SMBT-1.
Who it may be relevant to
Registry conditions: Parkinson Disease, Parkinson Disease Dementia, Parkinson's Disease and Parkinsonism. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To evaluate the potential usefulness of 18F-FPyCO/SMBT-1 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various MAO-B-related disease patients.

Detailed description

Subjects with various Tau-related disease patients underwent18F-FPyCO/SMBT-1 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FPyCO/SMBT-1 PET/CT were calculated.

Interventions

  • Diagnostic test Diagnostic Test: 18F-FPyCO/SMBT-1
    Each subject receive a single intravenous injection of 18F-FPyCO/SMBT-1, and undergo PET/ CT or MRI imaging within the specificed time.

Primary outcome measures

  • Standardized uptake value (SUV) [Time frame: 30 days]
Secondary outcome measures (1)
  • Diagnostic efficacy [Time frame: 30 days]

Eligibility criteria

Inclusion criteria

\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated PD (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled TSPO PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

  • patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 2 centers
  • The First Affiliated Hospital of University of Science and Technology of China — Hefei
  • Tianjin Medical University General Hospital — Tianjin

Identifiers

NCT: NCT07685873 · TJMUGH-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗