HealthyPhase 1NCT07253753
A Study to Evaluate Safety and Dosimetry of [18F]4-FDF, a New PET Imaging Agent for Inflammation
A Phase 1 study testing NeuCaVis in people with Healthy, run by Yellowbird Diagnostics Inc at 1 site in Canada.
Trial summary
A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NeuCaVis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 8 Apr 2026to 17 Jun 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, ages 18-55 years inclusively at time of consent
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusively
- Capable of providing informed consent
- Able to speak and read in English or French
- Able to comply with all study procedures (including fasting for 12 hours, lying still in a supine position for about 90 minutes)
Who cannot join
- Known hypersensitivity NeuCaVis or its excipients
- Blood glucose level higher than 200mg/dl at screening
- Active viral infection at screening
- Currently taking anti-inflammatory medications (e.g. ASA, NSAIDs, corticosteroids, immunomodulating agents, colchicine)
- Any anatomical heart abnormality, or cardiovascular condition including acute cardiac condition, suspicion of cardiac inflammation, and/or coronary artery disease, that may confound the analysis of the data based on the investigator's clinical opinion.
- Recent (in the past 6 months) history of head trauma
Show all 14Show fewer
- Abnormal and clinically significant results on the physical examination, vital signs, or laboratory tests at screening.
- Clinically significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
- Female participants who are pregnant, planning to become pregnant during the study or breastfeeding
- If of childbearing potential, unwilling or unable to use of a highly effective method of contraception as outlined in the protocol for the duration of the study.
- Any contraindication to PET or CT imaging.
- Actively participating in other interventional clinical trial(s).
- Unwilling to comply with study procedures, medication restrictions or attend all study visits
- Any other condition that, in the opinion of the investigator, could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Evaluation of Novel Imaging Diagnostic Agent NeuCaVis in Healthy Volunteers
A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). However, because the brain and heart naturally use a lot of glucose, the images can have background 'noise' making it harder for doctors to see signs of disease in these organs.
NeuCaVis is a new type of radiotracer that is being investigated in this study. It works by showing us how the body uses different kind of sugar, fructose. Outside of the digestive system, fructose is not normally used by healthy tissues. It is only used for energy when inflammation is present.
Read more
The purpose of this study is to evaluate the safety, tolerability and how NeuCaVis is distributed in normal tissue throughout the body. This is the first time this is being tested in people.
Participants will undergo a series of PET/CT scans following an intravenous injection of NeuCaVis. The first will be 90 minutes, then a 25 minute break, followed by a 10 minute scan, a 105 minute break, then a final 10 minute scan. A follow up phone call will occur 1-3 days later. In the optional sub-set study, participants will return to the clinic approximately 1-2 weeks after the first scan. The additional PET scan is already used in medical care and involves administration of an approved PET radiotracer, [18F]FDG. Researchers would compare this scan to the study PET scan with NeuCaVis. For this standard of care scan, it would be necessary to fast (not to eat or drink anything, except water) for at least 12 hours prior to receiving the FDG radiotracer injection.
- Conditions
- Healthy
- Being tested
- NeuCaVis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuCaVisDrug
PET radiotracer
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | NeuCaVis Receives: Drug: NeuCaVis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Categorized by type, severity and relationship
Measured: Adverse events are collected on each day participants undergo PET scanning (Day 1 and optional sub-study Day 8-15) and at safety follow-up visits two days post scanning.
Secondary outcomes (6)
Radiotracer uptake measured in major organs
Measured by SUV and mean uptake time for radiotracer. Visual analysis for any non-physiological radiotracer uptake.
Measured: Day 1
Whole blood and plasma radioactivity counts
Measured at 0.5 to 250 min post-injection. Time-activity curves (TACs) for major organs.
Measured: Day 1
Overall visual grading score
Measured by present or not present
Measured: Day 1
Qualitative scoring scale
Measured by none (0), minimal (1), mild (2), moderate (3), severe (4) for LV myocardium
Measured: Day 1
Image quality
Measured by non-diagnostic (0), poor (1), fair (2), good (3), excellent (4)
Measured: Day 1
Cardiac and brain uptake
Measured by none (0), minimal (1), mild (2), moderate (3), extreme (4)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start8 Apr 2026
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yellowbird Diagnostics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benjamin Chow, MD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253753
- Sponsor's protocol ID
- YB-NCV-001
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2025
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of Novel Imaging Diagnostic Agent NeuCaVis in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07253753
- Acronym / sponsor ID
- YB-NCV-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yellowbird Diagnostics IncIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2026 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 28 Nov 2025 (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.
A standard imaging test used to look for disease in the body is a positron emission tomography (PET) scan. These scans use a small amount of a radioactive substance, called a radiotracer. The most commonly used radiotracer is FDG, which shows us how the body uses glucose (a type of sugar). However, because the brain and heart naturally use a lot of glucose, the images can have background 'noise' making it harder for doctors to see signs of disease in these organs.
NeuCaVis is a new type of radiotracer that is being investigated in this study. It works by showing us how the body uses different kind of sugar, fructose. Outside of the digestive system, fructose is not normally used by healthy tissues. It is only used for energy when inflammation is present.
The purpose of this study is to evaluate the safety, tolerability and how NeuCaVis is distributed in normal tissue throughout the body. This is the first time this is being tested in people.
Participants will undergo a series of PET/CT scans following an intravenous injection of NeuCaVis. The first will be 90 minutes, then a 25 minute break, followed by a 10 minute scan, a 105 minute break, then a final 10 minute scan. A follow up phone call will occur 1-3 days later. In the optional sub-set study, participants will return to the clinic approximately 1-2 weeks after the first scan. The additional PET scan is already used in medical care and involves administration of an approved PET radiotracer, [18F]FDG. Researchers would compare this scan to the study PET scan with NeuCaVis. For this standard of care scan, it would be necessary to fast (not to eat or drink anything, except water) for at least 12 hours prior to receiving the FDG radiotracer injection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: NeuCaVisNeuCaVis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female, ages 18-55 years inclusively at time of consent
- Body Mass Index (BMI) of 18 to 30 kg/m2, inclusively
- Capable of providing informed consent
- Able to speak and read in English or French
- Able to comply with all study procedures (including fasting for 12 hours, lying still in a supine position for about 90 minutes)
Key exclusion criteria (14 listed)
- Known hypersensitivity NeuCaVis or its excipients
- Blood glucose level higher than 200mg/dl at screening
- Active viral infection at screening
- Currently taking anti-inflammatory medications (e.g. ASA, NSAIDs, corticosteroids, immunomodulating agents, colchicine)
- Any anatomical heart abnormality, or cardiovascular condition including acute cardiac condition, suspicion of cardiac inflammation, and/or coronary artery disease, that may confound the analysis of the data based on the investigator's clinical opinion.
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 |
|---|---|---|
| NeuCaVisPET radiotracer | Drug | Active |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)
Time frame: Adverse events are collected on each day participants undergo PET scanning (Day 1 and optional sub-study Day 8-15) and at safety follow-up visits two days post scanning.
Categorized by type, severity and relationship
6 secondary outcomes
Radiotracer uptake measured in major organs
Time frame: Day 1
Whole blood and plasma radioactivity counts
Time frame: Day 1
Overall visual grading score
Time frame: Day 1
Qualitative scoring scale
Time frame: Day 1
Image quality
Time frame: Day 1
Cardiac and brain uptake
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- 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.
Benjamin Chow, MD principal investigator
Ottawa Heart Institute Research Corporation
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 NeuCaVis in people with Healthy, run by Yellowbird Diagnostics Inc at 1 site in Canada.
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 5 inclusion and 14 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: finished, as of the sponsor's last update on 23 Jun 2026. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs) (time frame: Adverse events are collected on each day participants undergo PET scanning (Day 1 and optional sub-study Day 8-15) and at safety follow-up visits two days post scanning.). 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 23 Jun 2026.