Safety and body distribution of NeuCaVis, a new PET tracer that uses fructose, in healthy adults

Phase 1 Evaluation of Novel Imaging Diagnostic Agent NeuCaVis in Healthy Volunteers

This trial will test whether NeuCaVis, a new PET imaging tracer that uses fructose, is safe and how it spreads through the body in healthy adults aged 18–55.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Yellowbird Diagnostics Inc (Industry-sponsored)
• Locations: 1 site (Ottawa, Ontario)
• Trial ID: NCT07253753 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, Phase 1 trial of NeuCaVis, a PET radiotracer that targets fructose uptake associated with inflammation. Healthy volunteers will receive a single injection of NeuCaVis followed by serial PET imaging to measure whole-body distribution and radiation dosimetry, with subjects fasting and lying still during imaging sessions. Safety and tolerability will be monitored through clinical assessments and laboratory tests. The study excludes people with active infections, recent head trauma, significant cardiac abnormalities, or current use of anti-inflammatory medications to avoid confounding tracer uptake and safety signals.

Who should consider this trial

Good fit: Ideal participants are healthy adults aged 18–55 with a BMI of 18–30 who can fast and lie still for imaging and who do not have active infections, recent head trauma, significant heart conditions, or current use of anti-inflammatory drugs.

Not a fit: People with active infections, inflammatory disease, recent head trauma, cardiovascular abnormalities, or those taking anti-inflammatory or immunomodulating medications would not be expected to benefit and are excluded from participation.

Why it matters

Potential benefit: If successful, NeuCaVis could provide clearer PET images of inflammation in organs like the brain and heart, helping doctors detect and monitor inflammatory conditions more accurately.

How similar studies have performed: This is the first human test of NeuCaVis, while PET imaging with glucose-based tracers like FDG is well established; targeting fructose uptake for inflammation imaging is a relatively new approach with limited prior human data.

Eligibility criteria

Inclusion Criteria:

1. Male or female, ages 18-55 years inclusively at time of consent
2. Body Mass Index (BMI) of 18 to 30 kg/m2, inclusively
3. Capable of providing informed consent
4. Able to speak and read in English or French
5. Able to comply with all study procedures (including fasting for 12 hours, lying still in a supine position for about 90 minutes)

Exclusion Criteria:

1. Known hypersensitivity NeuCaVis or its excipients
2. Blood glucose level higher than 200mg/dl at screening
3. Active viral infection at screening
4. Currently taking anti-inflammatory medications (e.g. ASA, NSAIDs, corticosteroids, immunomodulating agents, colchicine)
5. 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.
6. Recent (in the past 6 months) history of head trauma
7. Abnormal and clinically significant results on the physical examination, vital signs, or laboratory tests at screening.
8. Clinically significant neurologic, neurodevelopmental, cardiovascular, renal, hepatic, hematological, gastrointestinal, pulmonary, or metabolic-endocrine disorder
9. Female participants who are pregnant, planning to become pregnant during the study or breastfeeding
10. 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.
11. Any contraindication to PET or CT imaging.
12. Actively participating in other interventional clinical trial(s).
13. Unwilling to comply with study procedures, medication restrictions or attend all study visits
14. 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.

Where this trial is running

Ottawa, Ontario

• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Benjamin Chow, MD — Ottawa Heart Institute Research Corporation

Conditions Healthy