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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-01

Study Completion Date

2028-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Alpha Synuclein Pathology Alpha-Synuclein Parkinson Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Group Assignment

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.

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes