NCT06949670

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Tianjin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Alpha Synuclein Pathology
• Alpha-Synuclein
• Parkinson Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2025-04-29
• Last updated: 2026-01-29

Locations

2 sites across 1 country: China