Normal Healthy AdultsPhase 1F18TRACKNCT05427656
Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain
A Phase 1 study testing [18F] TRACK and Measurement of Arterial Input Function in people with Normal Healthy Adults, run by Thiel, Alexander, M.D..
Trial summary
Following our recently completed whole body dosimetry study for [18F] TRACK in 6 healthy control subjects, the objective of this project is to evaluate brain uptake, regional distribution and in vivo pharmacokinetics for [18F] TRACK in 30 cognitively healthy controls using dynamic PET imaging. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Healthy Adults
- What is being tested?
- [18F] TRACK and Measurement of Arterial Input Function
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to Aug 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In order to be considered a healthy control, participants will have a Clinical Dementia Rating (CDR) of 0, Montreal Cognitive Assessment (MoCA) greater than or equal to 26 and Mini-Mental State Exam (MMSE) of 24 or greater, with normal results on the Logical Memory 2 score from the Wechsler Memory Scale-Revise (cut-offs adjusted by education level), and normal scores on the Jessen questions for subjective memory complaints [21]. For the arterial catheter insertion, participants must have two viable arteries of the hand/arm. Women of childbearing potential must undergo a urine pregnancy test and may only be included if the urine pregnancy test is negative.
Who cannot join
- Exclusion Criteria: When screening participants, we will question them as to whether they have participated in any other research studies over the past year in which they would have been exposed to radiation. Should they indicate that they have, we would not include them into the present study. A detailed questionnaire regarding Magnetic Resonance Imaging contraindications will be completed with each participant. Should they have any of the following, they will be excluded: cardiac pacemaker, an aneurysm clip, a metal prosthesis (e.g. artificial joints), an artificial heart valve or a metal clip on a blood vessel, metal in the eye or body, tattoos, body piercings, transdermal delivery systems (e.g. patch) or if they suffer from acute claustrophobia. Participants with any psychiatric or neurological conditions that could affect the brain will not be allowed to participate.
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About this study
Official title: Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain (Uptake, Distribution and Pharmacokinetic) Study
Following our recently completed whole body dosimetry study for [18F] TRACK in 6 healthy control subjects, the objective of this project is to evaluate brain uptake, regional distribution and in vivo pharmacokinetics for [18F] TRACK in 30 cognitively healthy controls using dynamic PET imaging. Specifically, we will evaluate [18F] TRACK in three cohorts of healthy control subjects of different ages and both sexes to further explore tracer kinetics in vivo and to determine the most appropriate and robust model to estimate tracer binding to TrkB/C. This will assess normal TrkB/C density in vivo and provide normative data for future use of these tracers in patients.
Read the detailed description
We propose to use the radiotracer [18F] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with Positron Emission Tomography in 3 different age cohorts. The different subgroups of healthy controls will be used to define the best quantification method for our TrkB/C ligands and to assess a possible age dependency of TrkB/C binding in the healthy population, that may be of particular importance for the future study of patients with Alzheimer's Disearse or mild cognitive impairment. We expect the proposed study to result in 1) a non-invasive method to quantify TrkB/C receptor binding in vivo, 2) age-specific norms of TrkB/C concentration and 3) a simplified approach for quantification which best approximates the full model without the need for arterial blood sampling for future use in patients.
- Conditions
- Normal Healthy Adults
- Being tested
- [18F] TRACK, Measurement of Arterial Input Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] TRACKRadiation
We propose to use the radiotracer [18F] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with PET in the 3 cohorts. The different subgroups of healthy controls will be used to define the best quantification method for our TrkB/C ligands and to assess a possible age dependency of TrkB/C binding in the healthy population, and may be of particular importance for the future study of patients with Alzheimer's Disease or mild cognitive impairment. Each participantsubject will receive a single scan with 185 MBq [18F] TRACK injected into an antecubital vein. Dynamic PET data will be acquired in list mode for 90 minutes ([18F] TRACK) respectively on a CTI/Siemens HRRT PET scanner at the brain imaging center of the Montreal Neurological Institute following our published procedure for [18F] TRACK after a transmission scan.
Measurement of Arterial Input FunctionDevice
Also called Non-Invasive Detector
The non-invasive detector, hereinafter called NID, comprises of plastic scintillating fibers (BCF-12, St-Gobain, France) wrapped in a medical-grade acrylic heat-shrink tube (Vention Medical, USA). The scintillating fibers are coupled to 5 m long transmission fibers to bring the signal out of the PET detector. The fibers will be held in place using a 3D-printed structure composed poly-lactic acid. The NID is designed to measure both positrons and photons escaping the wrist. Post-processing software is used to calculate the arterial input function.
| Study group | Role | What they receive |
|---|---|---|
| 185 MBq [18F] TRACK | Experimental | Each participant will receive a single scan with 185 MBq [18F] TRACK Receives: Radiation: [18F] TRACK; Device: Measurement of Arterial Input Function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive method to quantify TrkB/C receptor binding in vivo
Non-invasive method to quantify TrkB/C receptor binding in vivo
Measured: One Year
Age-specific norms of TrkB/C concentration
Age-specific norms of TrkB/C concentration
Measured: One Year
Secondary outcomes (1)
Arterial Input Function with Non-Invasive Detector
A simplified approach for quantification which best approximates the full model without the need for arterial blood sampling for future use in patients.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start1 Aug 2022 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Healthy AdultsStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- We will study a total of 30 participants, 10 in each of 3 age cohorts 18-29, 30-59 and 60-89, with equal numbers of male and female participants in each cohort.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thiel, Alexander, M.D.
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427656
- Sponsor's protocol ID
- MP-05-2023-3358
- Acronym
- F18TRACK
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- 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 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain (Uptake, Distribution and Pharmacokinetic) Study
- ClinicalTrials.gov ID
- NCT05427656
- Acronym / sponsor ID
- F18TRACK / MP-05-2023-3358
- Conditions
- Normal Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thiel, Alexander, M.D.
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Alberta
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 22 Jun 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.
Following our recently completed whole body dosimetry study for [18F] TRACK in 6 healthy control subjects, the objective of this project is to evaluate brain uptake, regional distribution and in vivo pharmacokinetics for [18F] TRACK in 30 cognitively healthy controls using dynamic PET imaging. Specifically, we will evaluate [18F] TRACK in three cohorts of healthy control subjects of different ages and both sexes to further explore tracer kinetics in vivo and to determine the most appropriate and robust model to estimate tracer binding to TrkB/C. This will assess normal TrkB/C density in vivo and provide normative data for future use of these tracers in patients.
Detailed description
We propose to use the radiotracer [18F] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with Positron Emission Tomography in 3 different age cohorts. The different subgroups of healthy controls will be used to define the best quantification method for our TrkB/C ligands and to assess a possible age dependency of TrkB/C binding in the healthy population, that may be of particular importance for the future study of patients with Alzheimer's Disearse or mild cognitive impairment. We expect the proposed study to result in 1) a non-invasive method to quantify TrkB/C receptor binding in vivo, 2) age-specific norms of TrkB/C concentration and 3) a simplified approach for quantification which best approximates the full model without the need for arterial blood sampling for future use in patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- We will study a total of 30 participants, 10 in each of 3 age cohorts 18-29, 30-59 and 60-89, with equal numbers of male and female participants in each cohort.
| Arm | Type | Receives |
|---|---|---|
| 185 MBq [18F] TRACK | Experimental | Radiation: [18F] TRACK, Device: Measurement of Arterial Input FunctionEach participant will receive a single scan with 185 MBq [18F] TRACK |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In order to be considered a healthy control, participants will have a Clinical Dementia Rating (CDR) of 0, Montreal Cognitive Assessment (MoCA) greater than or equal to 26 and Mini-Mental State Exam (MMSE) of 24 or greater, with normal results on the Logical Memory 2 score from the Wechsler Memory Scale-Revise (cut-offs adjusted by education level), and normal scores on the Jessen questions for subjective memory complaints [21]. For the arterial catheter insertion, participants must have two viable arteries of the hand/arm. Women of childbearing potential must undergo a urine pregnancy test and may only be included if the urine pregnancy test is negative.
Key exclusion criteria (2 listed)
- Exclusion Criteria: When screening participants, we will question them as to whether they have participated in any other research studies over the past year in which they would have been exposed to radiation. Should they indicate that they have, we would not include them into the present study. A detailed questionnaire regarding Magnetic Resonance Imaging contraindications will be completed with each participant. Should they have any of the following, they will be excluded: cardiac pacemaker, an aneurysm clip, a metal prosthesis (e.g. artificial joints), an artificial heart valve or a metal clip on a blood vessel, metal in the eye or body, tattoos, body piercings, transdermal delivery systems (e.g. patch) or if they suffer from acute claustrophobia. Participants with any psychiatric or neurological conditions that could affect the brain will not be allowed to participate.
- -
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] TRACKWe propose to use the radiotracer [18F] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with PET in the 3 cohorts. The different subgroups of healthy controls will be used to define the best quantification method for our TrkB/C ligands and to assess a possible age dependency of TrkB/C binding in the healthy population, and may be of particular importance for the future study of patients with Alzheimer's Disease or mild cognitive impairment. Each participantsubject will receive a single scan with 185 MBq [18F] TRACK injected into an antecubital vein. Dynamic PET data will be acquired in list mode for 90 minutes ([18F] TRACK) respectively on a CTI/Siemens HRRT PET scanner at the brain imaging center of the Montreal Neurological Institute following our published procedure for [18F] TRACK after a transmission scan. | Radiation | 185 MBq [18F] TRACK |
| Measurement of Arterial Input FunctionAlso: Non-Invasive DetectorThe non-invasive detector, hereinafter called NID, comprises of plastic scintillating fibers (BCF-12, St-Gobain, France) wrapped in a medical-grade acrylic heat-shrink tube (Vention Medical, USA). The scintillating fibers are coupled to 5 m long transmission fibers to bring the signal out of the PET detector. The fibers will be held in place using a 3D-printed structure composed poly-lactic acid. The NID is designed to measure both positrons and photons escaping the wrist. Post-processing software is used to calculate the arterial input function. | Device | 185 MBq [18F] TRACK |
Primary outcome
Non-invasive method to quantify TrkB/C receptor binding in vivo
Time frame: One Year
Non-invasive method to quantify TrkB/C receptor binding in vivo
Age-specific norms of TrkB/C concentration
Time frame: One Year
Age-specific norms of TrkB/C concentration
1 secondary outcome
Arterial Input Function with Non-Invasive Detector
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F] TRACK and Measurement of Arterial Input Function in people with Normal Healthy Adults, run by Thiel, Alexander, M.D..
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 1 inclusion and 2 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 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive method to quantify TrkB/C receptor binding in vivo (time frame: One Year). The study lists 2 primary outcomes in all. 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 21 Jul 2022.