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NCT Number: NCT06949670

Alpha-Synuclein PET/CT in Various α-Syn-Related Disease

To evaluate the potential usefulness of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various α-Syn-related disease patients.

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Key information

Conditions

Alpha Synuclein Pathology Alpha-Synuclein Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parkinson Disease Parkinson Disease 4, Autosomal Dominant Lewy Body Parkinsonian Disorders Proteostasis Deficiencies Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui, China

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About this study

Subjects with various α-Syn-related disease patients underwent 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 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-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 PET/CT were calculated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 α-Syn 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

  • (i) patients with none PD syndrome; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Treatment and study plan

18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06

Diagnostic Test

Each subject receive a single intravenous injection of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 and undergo PET/CT or MRI imaging within the specificed time.

Primary outcomes

  1. Standardized uptake value (SUV)

    Time frame: 30 days

    Standardized uptake value (SUV) of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity and accuracy of α-Syn PET/CT were calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Li Cai, MD

CONTACT

[email protected]

+862260362190

Ying Wang, MD

CONTACT

[email protected]

+8618702292537

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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