Alpha-Synuclein PET/CT in Various α-Syn-Related Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 3
- Primary Endpoint
- Standardized uptake value (SUV)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
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.
Intervention: 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 (Diagnostic Test)
Outcomes
Primary Outcomes
Standardized uptake value (SUV)
Time Frame: 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 Outcomes
- Diagnostic efficacy(30 days)
Investigators
Shaobo Yao, PhD
Prof.
Tianjin Medical University