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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06949670

Enrollment

500

Registered

2025-04-29

Start date

2025-04-01

Completion date

2028-04-01

Last updated

2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alpha-Synuclein, Alpha Synuclein Pathology, Parkinson Disease

Keywords

PET/CT, MRI, Alpha-Synuclein

Brief 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.

Interventions

DIAGNOSTIC_TEST18F-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Standardized uptake value (SUV)	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

Measure	Time frame	Description
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of α-Syn PET/CT were calculated.

Countries

China

Contacts

CONTACTYing Wang, MD

macrossplusvoices@163.com+8618702292537

CONTACTLi Cai, MD

xcl242004@126.com+862260362190

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026