NCT06890390RecruitingNot Applicable
TSPO PET in the Evaluation of Neuroinflammation in Patients with Multiple System Atrophy
Min Zhao,MD1 site in 1 country90 target enrollmentStarted: September 14, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Standard uptake value ratio(SUVR)
Study Overview
Brief Summary
The aim of this study was to apply PET/MR techniques targeting TSPO to explore the temporal and spatial alterations characterizing neuroinflammation in MSA patients, and to assess its value as a biomarker for diagnostic typing, disease severity, and prognosis of MSA disease.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age> 35 years old, gender is not limited;
- •Clinically confirmed MSA and clinically probable MSA according to the 2022 MDS MSA diagnostic criteria;
- •all patients had been ruled out of polyQ disease by genetic testing;
- •Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria
- •pregnancy or breastfeeding;
- •contraindications to MRI examination or inability to cooperate in completing neuroimaging examination;
- •previous history of other neurological disorders or presence of other organic intracranial lesions on neuroimaging that cannot be interpreted by MSA, such as epilepsy, trauma, tumors, or high-grade cerebral white matter degeneration (Fazekas grade 2 and above);
- •History of alcohol or drug abuse
Outcomes
Primary Outcomes
Standard uptake value ratio(SUVR)
Time Frame: From enrollment to the end of treatment at 4 weeks
Secondary Outcomes
- H-Y stage(From enrollment to the end of treatment at 4 weeks)
- Wexner score(From enrollment to the end of treatment at 4 weeks)
- UMSARS(From enrollment to the end of treatment at 4 weeks)
- SCOPA-AUT(From enrollment to the end of treatment at 4 weeks)
- Frontal Assessment Battery(From enrollment to the end of treatment at 4 weeks)
- MoCA score(From enrollment to the end of treatment at 4 weeks)
- TSPO Single nucleotide polymorphism genotyping(From enrollment to the end of treatment at 4 weeks)
Investigators
Study Sites (1)
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