About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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.

Disqualifiers

(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 population

(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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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.

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Single Group Assignment1 intervention

Trial outcomes

Primary outcomes

1

Standardized uptake value (SUV)

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.

Time frame

30 days

Secondary outcomes

1

Diagnostic efficacy

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