Neurodegenerative DementiaEarly Phase 1NCT03620552
18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
A Early Phase 1 study testing 18F-S16 in people with Neurodegenerative Dementia, run by Oriental Neurosurgery Evidence-Based-Study Team at 1 site in China.
Trial summary
This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurodegenerative Dementia
- What is being tested?
- 18F-S16
- 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
- 20 Aug 2017to 20 Feb 2019
- Phase
- Early 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with Neurodegenerative Dementia
- Males and females, ≥40 years old
- They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.
Who cannot join
- Females planning to bear a child recently or with childbearing potential
- Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- 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.
- Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, 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
PET/CT center,Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Li Cai, MD
About this study
Official title: Safety and Diagnostic Performance of 18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
This is an open-label dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia.
Read the detailed description
For interests in clinical translation of 18F-S16, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 18F-S16 in patients with neurodegenerative dementia. A single dose of nearly 370 MBq 18F-S16 will be intravenously injected into healthy volunteers and patients with neurodegenerative dementia. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the subjects. Adverse events will also be observed in the subjects.
- Conditions
- Neurodegenerative Dementia
- Being tested
- 18F-S16
- Keywords
- 18F-S16, Neurodegenerative Dementia, PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-S16Drug
A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| 18F-S16 injection and PET/CT scan | Experimental | The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection. Receives: Drug: 18F-S16 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semiquantitative assessment of lesions and biodistribution
The semiquantitative analysis will be performed by the same physician for all the cases, and the standardized uptake values (SUVs) of brain and other organs will be measured.
Measured: One year
Secondary outcomes (8)
Blood pressure
Systolic and diastolic pressure of subjects will be measured at three time points: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Pulse
Pulse will be measured at three time points for each subjects: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Respiration frequency
Respiration frequency will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Temperature
Temperature will be measured at three time points for subjects: right before injection, after scanning, and 24 hours after treatment.
Measured: 24 hours
Serum alanine aminotransferase
Serum alanine aminotransferase of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum albumin
Serum albumin of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Serum creatinine
Serum creatinine of subjects will be measured at two time points: right before injection and 24 hours after treatment.
Measured: 24 hours
Adverse events collection
Adverse events within 5 days after the injection and scanning of subjects will be followed and assessed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start20 Aug 2017
- Primary completion20 Oct 2018 (estimated)
- Study completion20 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DementiaStudies of the same condition, open and under way.
- 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
- Early 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
- Oriental Neurosurgery Evidence-Based-Study Team
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Cai, MD, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620552
- Sponsor's protocol ID
- S16AD2018
- Status last verified
- Jun 2018
- First submitted
- 29 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Diagnostic Performance of 18F-S16 PET/CT in Healthy Volunteers and Patients With Neurodegenerative Dementia
- ClinicalTrials.gov ID
- NCT03620552
- Acronym / sponsor ID
- S16AD2018
- Conditions
- Neurodegenerative Dementia
- Keywords
- 18F-S16, Neurodegenerative Dementia, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oriental Neurosurgery Evidence-Based-Study TeamUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 20 Oct 2018 (estimated)
- Study completion
- 20 Feb 2019 (estimated)
- First posted
- 8 Aug 2018 (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 dynamic whole-body PET/CT (positron emission tomography/computed tomography) study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 18F-S16 in healthy volunteers and patients with neurodegenerative dementia.
Detailed description
For interests in clinical translation of 18F-S16, an open-label dynamic whole-body PET/CT study was designed to investigate safety and diagnostic performance of 18F-S16 in patients with neurodegenerative dementia. A single dose of nearly 370 MBq 18F-S16 will be intravenously injected into healthy volunteers and patients with neurodegenerative dementia. Visual and semiquantitative method will be used to assess the PET/CT images. Changes of blood pressure, pulse, respiration, temperature, routine blood and urine tests, serum alanine aminotransferase, albumin, and creatinine, and any adverse events will be collected from the subjects. Adverse events will also be observed in the subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-S16 injection and PET/CT scan | Experimental | Drug: 18F-S16The subjects were intravenously injected with 370MBq 18F-S16 and underwent PET/CT scan immediately after the injection. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Neurodegenerative Dementia
- Males and females, ≥40 years old
- They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.
Key exclusion criteria (8 listed)
- Females planning to bear a child recently or with childbearing potential
- Renal function: serum creatinine >3.0 mg/dL (270 μM/L)
- Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
- Known severe allergy or hypersensitivity to IV radiographic contrast.
- Patients not able to enter the bore of the PET/CT scanner.
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 |
|---|---|---|
| 18F-S16A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans | Drug | 18F-S16 injection and PET/CT scan |
Primary outcome
Semiquantitative assessment of lesions and biodistribution
Time frame: One year
The semiquantitative analysis will be performed by the same physician for all the cases, and the standardized uptake values (SUVs) of brain and other organs will be measured.
8 secondary outcomes
Blood pressure
Time frame: 24 hours
Pulse
Time frame: 24 hours
Respiration frequency
Time frame: 24 hours
Temperature
Time frame: 24 hours
Serum alanine aminotransferase
Time frame: 24 hours
Serum albumin
Time frame: 24 hours
Serum creatinine
Time frame: 24 hours
Adverse events collection
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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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 Cai, MD study director
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-S16 in people with Neurodegenerative Dementia, run by Oriental Neurosurgery Evidence-Based-Study Team 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 3 inclusion and 8 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 8 Aug 2018. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Li Cai, MD (86-22-60362190, XCL242004@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semiquantitative assessment of lesions and biodistribution (time frame: One year). 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 8 Aug 2018.