ClinicalTrials.gg
Status unknownNCT05757804Updated Mar 14, 2023

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

An observational study in Positron-Emission Tomography and Alpha Synuclein Pathology, sponsored by Huashan Hospital. Status unknown at 1 site in China. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-14.

Sponsored by Huashan Hospital · Observational

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
20
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Positron-Emission Tomography
  • Alpha Synuclein Pathology

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Keywords

  • Alpha Synuclein Pathology, Positron Emission Tomography
03

In context

Synucleinopathies

38 studies on the registry are indexed under Synucleinopathies; 23 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 16 observational studies indexed under Synucleinopathies.

Browse Synucleinopathies studies →

Lead sponsor

Huashan Hospital is the lead sponsor of 247 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects were included from the neurology outpatient clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

-

Non-disease controls:

  1. Age between 60 and 80 years; gender is not limited.
  2. Normal motor function as determined by the investigator through testing; UPDRS score of 0.
  3. No neurological disease, major chronic disease, or acute infectious disease as confirmed by the investigator.
  4. must be signed in writing by the subject or his/her legal guardian or caregiver.
  5. Blood count: white blood cell count (WBC) 4-10×109/L; (PLT) 100-300×109/L; (HB) 120-160 g/L; renal function: serum creatinine less than or equal to the ; liver function: , (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range. : no significant abnormalities.
  6. 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.
  7. Be willing and able to cooperate with all the projects of this study.

PD patients:

  1. Age between 60 and 80 years old; gender is not limited.
  2. 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).
  3. Brain MRI supports the diagnosis of PD and there is no other evidence of neurological disease.
  4. No neurological disease, major chronic disease, malignancy or acute infectious disease as confirmed by the investigator.
  5. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
  6. 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.
  7. 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.
  8. Be willing and able to cooperate with all the projects of this study.

DLB patients:

  1. Age was between 60 and 80 years; gender was not restricted.
  2. Patients meet the diagnostic criteria for probable and likely Lewy body dementia developed by the International Working Group on Dementia with Lewy Bodies meeting
  3. The diagnosis of DLB was supported by brain MRI and there was no other evidence of neurological disease.
  4. No neurological disease, major chronic illness, malignancy, or acute infectious disease as confirmed by the investigator.
  5. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
  6. 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.
  7. 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.
  8. Be willing and able to cooperate with all the projects of this study.

MSA patients:

  1. Age was between 60 and 80 years old; gender was not limited.
  2. Patients meet the diagnostic criteria of the newly released 2022 MSA diagnostic consensus
  3. Brain MRI supported the diagnosis of MSA and no other evidence of neurological disease.
  4. No neurological disease, major chronic disease, malignancy, or acute infectious disease as confirmed by the investigator
  5. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
  6. 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.
  7. 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.
  8. Be willing and able to cooperate with all the projects of this study.

Exclusion criteria

Exclusion Criteria:

  • Subjects meeting any of the following criteria will be excluded from the study:

    1. Suffering from other serious neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor endocrine, respiratory system, immune deficiency and other serious diseases.
    2. 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.
    3. Liver function: , (SGOT)/ALT(SGPT) less than or equal to the .
    4. The candidate subject has received major surgery or received experimental drug or device treatment (with unclear effect or safety) within 1 month
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • Non-disease controls
  • PD patients
  • DLB patients
  • MSA patients
06

What researchers measure

Primary outcomes

  1. Complete PET imaging

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

    Time frame: 90mins from time of injection

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital
    Shanghai, 200040, China
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2023; primary completion for Jul 2023, 3 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2023
First posted
Mar 7, 2023
StartEst.
Mar 17, 2023
Primary completionEst.
Jul 15, 2023
CompletionEst.
Jan 14, 2024
Last update
Mar 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05757804
Lead sponsor
Huashan Hospital
Responsible party
YiHui Guan (Professor, Huashan Hospital) — Principal investigator
First posted
Mar 7, 2023
Start date
Mar 17, 2023 (estimated)
Primary completion
Jul 15, 2023 (estimated)
Completion
Jan 14, 2024 (estimated)
Last update
Mar 14, 2023

Study contacts

Yihui Guan, MD
Contact
guanyihui@hotmail.com
+86-13764308300
Fang Xie, PhD
principal investigator · Huashan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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