NeuCaVis for Inflammation Imaging

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Yellowbird Diagnostics Inc

Must not be taking: Anti-inflammatories

Disqualifiers: High blood glucose, Heart conditions, Neurologic disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging tracer called NeuCaVis, which enhances the visibility of inflammation during PET scans. NeuCaVis uses fructose, a sugar utilized by the body only when inflammation occurs, making it easier to detect issues in the brain and heart. The trial aims to assess the safety, tolerability, and distribution of NeuCaVis in the body. This trial may suit individuals aged 18 to 55 with a normal body weight who can fast and remain still for scans. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

If you are currently taking anti-inflammatory medications, you will need to stop taking them to participate in this trial.

What prior data suggests that NeuCaVis is safe for human use?

Research shows that NeuCaVis is a new substance being tested in humans for the first time, so limited safety information is available. However, since this trial is in its earliest stage, researchers have already conducted careful studies in the lab and on animals to ensure it is safe enough for human trials.

The study aims to assess how well people can tolerate NeuCaVis and how it moves through healthy tissues. NeuCaVis is designed to use fructose, which healthy tissues outside the digestive system typically do not use. This characteristic might enhance its visibility in imaging tests compared to other substances.

Although detailed safety information for NeuCaVis in humans is not yet available, the early stage of the trial ensures rigorous safety testing. Researchers will closely monitor participants after they receive the tracer to quickly address any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

NeuCaVis is unique because it uses the novel tracer [18F]4-FDF to improve imaging of inflammation, potentially providing more precise and earlier detection than current options like standard MRI or CT scans. Unlike these conventional imaging techniques that rely on indirect signs of inflammation, [18F]4-FDF directly targets inflammatory processes, offering a clearer picture of what's happening in the body. Researchers are excited about this treatment because it could lead to faster and more accurate diagnoses, ultimately improving treatment outcomes for patients with inflammatory conditions.

What evidence suggests that NeuCaVis is effective for inflammation imaging?

Research has shown that NeuCaVis, the investigational treatment in this trial, targets inflammation using a type of sugar called fructose. Unlike the usual PET scan, which uses glucose, NeuCaVis might highlight inflamed areas more clearly, especially in the brain and heart, because healthy tissues don't typically use fructose. Early animal studies suggested it could provide better images of inflammation. This new imaging tool could help doctors see signs of disease more clearly. The study aims to test NeuCaVis in humans for the first time. ^{1 4 6 7 8}

Who Is on the Research Team?

Benjamin Chow, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for healthy individuals who are interested in participating in a study to test the safety and distribution of a new PET scan radiotracer called NeuCaVis. Participants will undergo several scans after receiving an injection of NeuCaVis, with follow-up calls or visits.

Inclusion Criteria

Body Mass Index (BMI) of 18 to 30 kg/m2, inclusively

Able to comply with all study procedures (including fasting for 12 hours, lying still in a supine position for about 90 minutes)

I am between 18 and 55 years old.

Exclusion Criteria

Known hypersensitivity NeuCaVis or its excipients

Blood glucose level higher than 200mg/dl at screening

Active viral infection at screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo a series of PET/CT scans following an intravenous injection of NeuCaVis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-3 days

1 follow-up call

Optional Sub-study

Participants may return for an additional PET scan with an approved PET radiotracer

1-2 weeks after initial scan

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• [18F]4-FDF

Trial Overview NeuCaVis, a novel radiotracer for PET scans that targets fructose utilization rather than glucose, is being tested. This could potentially reduce background noise in images of the brain and heart. The study involves multiple scanning sessions and possibly comparing it with standard FDG radiotracers.

How Is the Trial Designed?

Group I: Active Experimental Treatment 1 Intervention

NeuCaVis

Who Is Running the Clinical Trial?

Yellowbird Diagnostics Inc

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07253753

A Study to Evaluate Safety and Dosimetry of [18F]4-FDF, a ... A Study to Evaluate Safety and Dosimetry of [18F]4-FDF, a New PET Imaging Agent for Inflammation. ClinicalTrials.gov ID NCT07253753. Sponsor ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11898807/

18F-Fluorodeoxyglucose Imaging for Assessing ... Positron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) is a valuable non-invasive imaging tool for identifying active cardiovascular inflammation ...

3. jnm.snmjournals.org jnm.snmjournals.org/content/65/3/475

It's a Trap! Aldolase-Prescribed C 4 Deoxyradiofluorination ... Imaging of inflammation in brain and heart. [18F]4-FDF PET/CT was performed on mice receiving vehicle (A) or bacterial cell wall ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8271312/

State of the art of 18F-FDG PET/CT application in inflammation ... However, also [18F]FDG PET/CT is gaining an interesting role in imaging infections and inflammation particularly in lesions of the forefoot [27]. Nevertheless, ...

5. frontiersin.org frontiersin.org/journals/nuclear-medicine/articles/10.3389/fnume.2022.847810/full

18 F-FDG PET/CT Imaging: Normal Variants, Pitfalls, and ... This article aims to provide a pictorial review and analysis of cases that depict musculoskeletal, infective, and inflammatory uptake as normal variants, ...

6. lantheus.com lantheus.com/assets/fluorodeoxyglucose-f18_oct13-2015-2-1.pdf

SAFETY DATA SHEET Potential Health Effects SAFETY DATA SHEET ... Synonyms: FDG, (18F)FDG Fluorodeoxyglucose Injection. Product uses: This material is used as a medical imaging agent.

7. mayoclinic.org mayoclinic.org/drugs-supplements/fludeoxyglucose-f-18-intravenous-route/description/drg-20074508

Fludeoxyglucose f 18 (intravenous route) - Side effects & ... Fludeoxyglucose F 18 injection is used to help diagnose cancer, heart disease, and epilepsy. It is used in a procedure called a positron emission tomography ( ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2010/021870s004lbl.pdf

Fludeoxyglucose F18 Injection - accessdata.fda.gov Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose ...