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

Tianjin Medical University

Status: Enrolling

Conditions: Alpha-Synuclein; Parkinson Disease; Alpha Synuclein Pathology

Treatments: Diagnostic Test: 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06

Study type: Observational

Funder types: Other

Identifiers

NCT06949670

TJMUGH-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

500 participants in 1 patient group

Single Group Assignment

Description:

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.

Treatment:

Diagnostic Test: 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06