Patients With Central Nervous System DiseasesPhase 1NCT05335200
Clinical Applications of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases
A Phase 1 study testing (S)-[18F]FBFP PET/CT in people with Patients With Central Nervous System Diseases, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Patients With Central Nervous System Diseases
- What is being tested?
- (S)-[18F]FBFP PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Apr 2022to Dec 2024
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers: Males and females, ≥18 years old
- Patients With Central Nervous System Diseases: Patients with suspicion or diagnosis of central nervous system diseases after systemic neuropsychiatric assessment by experienced neurologists, having other imaging examination like CT or MRI, being able to provide basic information and sign the written informed consent form.
Who cannot join
- Females planning to bear a child recently or with childbearing potential
- Known severe allergy or hypersensitivity to [18F] radionuclides.
- Kidney or liver failure.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
- Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing
Yupei Zhao
About this study
Official title: Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases
This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases. A single dose of nearly 370 MBq (S)-[18F]FBFP will be intravenously injected into healthy volunteers and patients with central nervous system diseases. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
Read the detailed description
(S)-[18F]FBFP is a promising sigma-1 receptor radioligand. The sigma-1 receptor is a unique chaperone protein with 223 amino acids located at the mitochondria-associated endoplasmic reticulum membrane. Several lines of evidence have demonstrated that the sigma-1 receptor plays a pivotal role in the pathophysiology of many neuropsychiatric disorders including amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, Huntington's disease, pain, depression and drug addiction.Therefore, it is an important target for the investigation of neuropsychiatric disorders and drug development. PET imaging of sigma-1 receptors in the human brain will enable the elucidation of this target's involvement in neurologic disorders and will also facilitate new drug development.
For further interests in clinical translation of PET sigma-1 receptors radioligands, (S)-[18F]FBFP, an open-label whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases.
- Being tested
- (S)-[18F]FBFP PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(S)-[18F]FBFP PET/CTDiagnostic test
Patients will be intravenously injected with 185-370MBq (S)-[18F]FBFP and undergo serial whole-body PET/CT scans at multiple time points (5min, 15min, 30min, 45min, 1h, 2h, 4h). Safety assessment and tolerability of the study will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| (S)-[18F]FBFP injection and PET/CT scan | Experimental | Patients will be intravenously injected with(S)-[18F]FBFP and undergo PET/CT scan. Receives: Diagnostic Test: (S)-[18F]FBFP PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual and semiquantitative assessment of organs and biodistribution
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lesions or organs will be measured.
Measured: 1 month
Secondary outcomes (1)
Adverse events collection
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Central Nervous System DiseasesStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Normal University
- Responsible party
- Sponsor
- Investigators
- Li Huo, MD, Study chair, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05335200
- Sponsor's protocol ID
- PUMCHNM-SIGMA
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of (S)-[18F]FBFP PET/CT in Healthy Volunteers and Patients With Central Nervous System Diseases
- ClinicalTrials.gov ID
- NCT05335200
- Acronym / sponsor ID
- PUMCHNM-SIGMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Normal University
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Apr 2022 (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.
This is an open-label whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases. A single dose of nearly 370 MBq (S)-[18F]FBFP will be intravenously injected into healthy volunteers and patients with central nervous system diseases. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
Detailed description
(S)-[18F]FBFP is a promising sigma-1 receptor radioligand. The sigma-1 receptor is a unique chaperone protein with 223 amino acids located at the mitochondria-associated endoplasmic reticulum membrane. Several lines of evidence have demonstrated that the sigma-1 receptor plays a pivotal role in the pathophysiology of many neuropsychiatric disorders including amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, Huntington's disease, pain, depression and drug addiction.Therefore, it is an important target for the investigation of neuropsychiatric disorders and drug development. PET imaging of sigma-1 receptors in the human brain will enable the elucidation of this target's involvement in neurologic disorders and will also facilitate new drug development.
For further interests in clinical translation of PET sigma-1 receptors radioligands, (S)-[18F]FBFP, an open-label whole-body PET/CT study was designed to investigate radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of (S)-[18F]FBFP in healthy volunteers and patients with central nervous system diseases.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| (S)-[18F]FBFP injection and PET/CT scan | Experimental | Diagnostic Test: (S)-[18F]FBFP PET/CTPatients will be intravenously injected with(S)-[18F]FBFP and undergo PET/CT scan. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy volunteers: Males and females, ≥18 years old
- Patients With Central Nervous System Diseases: Patients with suspicion or diagnosis of central nervous system diseases after systemic neuropsychiatric assessment by experienced neurologists, having other imaging examination like CT or MRI, being able to provide basic information and sign the written informed consent form.
Key exclusion criteria (6 listed)
- Females planning to bear a child recently or with childbearing potential
- Known severe allergy or hypersensitivity to [18F] radionuclides.
- Kidney or liver failure.
- Patients not able to enter the bore of the PET/CT scanner.
- Inability to lie still for the entire imaging time because of cough, pain, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (S)-[18F]FBFP PET/CTPatients will be intravenously injected with 185-370MBq (S)-[18F]FBFP and undergo serial whole-body PET/CT scans at multiple time points (5min, 15min, 30min, 45min, 1h, 2h, 4h). Safety assessment and tolerability of the study will be conducted. | Diagnostic test | (S)-[18F]FBFP injection and PET/CT scan |
Primary outcome
Visual and semiquantitative assessment of organs and biodistribution
Time frame: 1 month
Visual analysis will be performed by consensus reading by at least 3 experienced nuclear medicine physician. The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake values (SUVs) of lesions or organs will be measured.
1 secondary outcome
Adverse events collection
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Li Huo, MD study chair
Peking Uion Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing (S)-[18F]FBFP PET/CT in people with Patients With Central Nervous System Diseases, run by Peking Union Medical College 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 2 inclusion and 6 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 19 Apr 2022. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jingnan Wang, MD (+86 13126715080, jingnanwang1991@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual and semiquantitative assessment of organs and biodistribution (time frame: 1 month). 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 19 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.