18F-4FN PET Imaging Agent for Inflammation Detection

Overseen By Sanjit Tewari, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Allergy to 18F-4FN, Obesity, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

55 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent called 18F-4FN (also known as 4-[18F]Fluoro-1-Naphthol) to detect inflammation in the body. Inflammation often involves immune cells like neutrophils and macrophages, which release chemicals that this agent can detect. The trial aims to evaluate the agent's effectiveness in identifying inflammation. Individuals diagnosed with a tumor and showing signs of inflammation from their treatment might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging agent.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that 18F-4FN is a new imaging agent used to detect inflammation in the body. Previous studies have examined the safety of this agent for humans, focusing on its movement through the body and any potential side effects.

In these studies, 18F-4FN quickly exited the body through the kidneys after injection, suggesting it doesn't remain in the body long, which is a positive sign for safety. While the research primarily aims to understand how the body processes the agent, no serious side effects have been reported so far.

Since this research is in its early stages, the main goal is to ensure the treatment's safety for humans. Researchers are closely monitoring for any side effects. However, because the treatment is still under investigation, not all aspects of its safety are known yet. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for inflammation rely on non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids, which mainly work by reducing pain and swelling. But the 4-[18F]Fluoro-1-Naphthol (4FN) imaging agent works differently, offering a way to visualize inflammation directly using PET scans. This innovative approach allows doctors to detect inflammation with greater precision, potentially leading to more accurate diagnoses and tailored treatment plans. Researchers are excited because this method could transform how inflammation is tracked and managed in various conditions, offering a new level of insight into patient health.

What evidence suggests that 18F-4FN is effective for inflammation detection?

Research shows that 18F-4FN is a promising new method for detecting inflammation in the body. This agent locates areas where immune cells, such as neutrophils and macrophages, gather during inflammation. These cells produce specific chemicals that 18F-4FN can detect. In lab tests, 18F-4FN accumulated in inflamed areas, enhancing visibility on scans. This method could help doctors identify and monitor inflammation more accurately. Early studies suggest that it exits the body quickly, potentially reducing side effects. Participants in this trial will receive one injection of 18F-4FN to evaluate its effectiveness and safety in detecting inflammation. ^{1 2 3 6 7}

Who Is on the Research Team?

Sanjit Tewari, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults diagnosed with endocrine tumors or inflammation due to immune checkpoint inhibitors can join. They must have normal kidney and liver function, not be allergic to the test substance, and weigh less than 400 pounds. Pregnant women, lactating mothers, and children under 18 are excluded.

Inclusion Criteria

My kidney and liver function tests are within normal ranges.

I have a tumor and have had side effects from immune therapy or suspected inflammation.

Exclusion Criteria

You weigh more than 400 pounds or your body mass index (BMI) is too high for the PET/CT scanner to safely support your weight.

I am not allergic to [18F]4FN.

Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 injection of 18F-4FN for PET imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and biodistribution after the injection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 4-[18F]Fluoro-1-Naphthol

Trial Overview The trial is testing a new PET imaging agent called 18F-4FN that may help visualize inflammation in patients with endocrine neoplasia by highlighting areas where certain immune cells gather.

How Is the Trial Designed?

Group I: 4-[18F]Fluoro-1-Naphthol Experimental Treatment 1 Intervention

Participants will receive 1 injection of \[18F\]4FN

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05335811

Study Details | NCT05335811 | First-in-Human Assessment ... Study Overview. Brief Summary. 18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits ...

2. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2021-0784.html

First-in-Human Assessment of Safety, Biodistribution and ... 18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01722

An Investigational Scan (18F-Fluoro-1-Naphthol [18F-4FN] ... This phase I trial studies the side effects of 4-[18F]fluoro-1-naphthol PET/CT for detecting inflammation in patients with cancer.

4. reporter.nih.gov reporter.nih.gov/search/No--f2wX-Ua7wL3ei6rX9Q/project-details/11212657

RePORT RePORTER - National Institutes of Health (NIH) | Patients will receive one to three [18F]4FN PET/CT scans and six to twelve Chronic GVHD Assessments. Data from these endpoints will be used to calculate ...

5. icrpartnership.org icrpartnership.org/project/167636

Project Details [18F]4FN provides a convenient reagent for rapid, quantitative whole-body imaging to identify and monitor inflammatory foci generated by NADPH oxidase-2 (NOX2) ...

6. reporter.nih.gov reporter.nih.gov/project-details/11212657

Project Details - NIH RePORTER This project will investigate if a novel radiotracer, 4-[18F]fluoro-1-naphthol, can identify and predict for the development of chronic GVHD and its response to ...

7. withpower.com withpower.com/trial/phase-1-endocrine-gland-neoplasms-7-2022-8118e

18F-4FN PET Imaging Agent for Inflammation Detection This Phase 1 medical study run by M.D. Anderson Cancer Center is evaluating whether 4-[18F]Fluoro-1-Naphthol will have tolerable side effects & efficacy for ...