Positron-Emission TomographyNCT05757804
Study of 18F-0502B PET Imaging Targeting α-synuclein in the Diagnosis of α-synuclein-related Diseases
An observational study of Positron-Emission Tomography and Alpha Synuclein Pathology, run by Huashan Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Positron-Emission Tomography, Alpha Synuclein Pathology
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2023to 14 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were included from the neurology outpatient clinic
Who may be able to join
- -
- 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.
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- 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.
- 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.
- DLB patients:
- Age was between 60 and 80 years; gender was not restricted.
- Patients meet the diagnostic criteria for probable and likely Lewy body dementia developed by the International Working Group on Dementia with Lewy Bodies meeting
- The diagnosis of DLB was supported by brain MRI and there was no other evidence of neurological disease.
- No neurological disease, major chronic illness, 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.
- MSA patients:
- Age was between 60 and 80 years old; gender was not limited.
- Patients meet the diagnostic criteria of the newly released 2022 MSA diagnostic consensus
- Brain MRI supported the diagnosis of MSA and 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.
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, 200040
Yihui Guan, +8613764308300, guanyihui@hotmail.com
About this study
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.
- Keywords
- Alpha Synuclein Pathology, Positron Emission Tomography
- Medical subject headings
- Synucleinopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-disease controls | Not described | |
| PD patients | Not described | |
| DLB patients | Not described | |
| MSA patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete PET imaging
Assessment of PET/CT imaging to detect α-synuclein in patients with α-synuclein-related Diseases
Measured: 90mins from time of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start17 Mar 2023 (estimated)
- Primary completion15 Jul 2023 (estimated)
- Study completion14 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positron-Emission TomographyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YiHui Guan, Huashan Hospital
- Investigators
- Fang Xie, PhD, Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05757804
- Sponsor's protocol ID
- KY2022-1065
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 18F-0502B PET Imaging Targeting α-synuclein in the Diagnosis of α-synuclein-related Diseases
- ClinicalTrials.gov ID
- NCT05757804
- Acronym / sponsor ID
- KY2022-1065
- Keywords
- Alpha Synuclein Pathology, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 17 Mar 2023 (estimated)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 14 Jan 2024 (estimated)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-disease controls | – | – |
| PD patients | – | – |
| DLB patients | – | – |
| MSA patients | – | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were included from the neurology outpatient clinic
Key inclusion criteria (36 listed)
- -
- 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.
Key exclusion criteria (5 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete PET imaging
Time frame: 90mins from time of injection
Assessment of PET/CT imaging to detect α-synuclein in patients with α-synuclein-related Diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Xie, PhD principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Positron-Emission Tomography and Alpha Synuclein Pathology, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 36 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yihui Guan, MD (+86-13764308300, guanyihui@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete PET imaging (time frame: 90mins from time of injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.