Study of 18F-0502B PET Imaging Targeting α-synuclein in the Diagnosis of α-synuclein-related Diseases

NCT05757804 | Unknown DMC

• 1 other identifier: KY2022-1065
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the diagnostic value of 18F-0502B brain imaging for α-Syn protein-related diseases in patients with PD. To evaluate the imaging range of α-Syn protein density in patients with α-Syn protein-related diseases and to assess the level of abnormal α-Syn protein deposition by PET imaging with this PET tracer, and its safety in human studies.

Conditions

Positron-Emission Tomography; Alpha Synuclein Pathology

Keywords

Alpha Synuclein Pathology, Positron Emission Tomography

Outcome Measures

Primary Outcomes (1)

• Complete PET imaging

  Assessment of PET/CT imaging to detect α-synuclein in patients with α-synuclein-related Diseases

  90mins from time of injection

Study Arms (4)

Non-disease controls

PD patients

DLB patients

MSA patients

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were included from the neurology outpatient clinic

You may qualify if:

• Non-disease controls:
• Age between 60 and 80 years; gender is not limited.
• Normal motor function as determined by the investigator through testing; UPDRS score of 0.
• No neurological disease, major chronic disease, malignancy or acute infectious disease as confirmed by the investigator.
• Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
• Blood count: white blood cell count (WBC) 4-10×109/L; platelets (PLT) 100-300×109/L; hemoglobin (HB) 120-160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; liver function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range. Electrocardiogram: no significant abnormalities.
• No neurological disorders, major chronic diseases, malignant tumors or acute infectious diseases as confirmed by the investigator, no family history of neurodegenerative movement disorders, no family history of neurological disorders related to movement disorders.
• Be willing and able to cooperate with all the projects of this study.
• PD patients:
• Age between 60 and 80 years old; gender is not limited.
• Patients meet the diagnostic criteria for PD (2015 version of the diagnostic guidelines for PD developed by the International Movement Disorders Society MDS), mild-moderate patients (H\&Y classification 1-3 inclusive).
• Brain MRI supports the diagnosis of PD and there is no other evidence of neurological disease.
• No neurological disease, major chronic disease, malignancy or acute infectious disease as confirmed by the investigator.
• Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
• Blood count: white blood cell count (WBC) 4-10×109/L; platelets (PLT) 100-300×109/L; hemoglobin (HB) 120-160 g/L; renal function: serum creatinine less than or equal to the upper limit of the normal range; liver function: bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range. Electrocardiogram: no significant abnormalities.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• Suffering from other serious neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor endocrine, respiratory system, immune deficiency and other serious diseases.
• In the past year, in addition to participating in the expected radiation exposure of this clinical study, have participated in other research programs or clinical care, resulting in radiation exposure exceeding the effective dose of 50 mSv.
• Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
• The candidate subject has received major surgery or received experimental drug or device treatment (with unclear effect or safety) within 1 month

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, 200040, China

RECRUITING

MeSH Terms

Conditions

Synucleinopathies

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fang Xie, PhD

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yihui Guan, MD

CONTACT

+86-13764308300; guanyihui@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: March 17, 2023
• Primary Completion: July 15, 2023
• Study Completion: January 14, 2024
• Last Updated: March 14, 2023

Record last verified: 2023-03

Locations

CN (1)