18F-4FN PET Imaging Agent for Inflammation Detection

Overseen By Lesley Flynt, 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

Trial Summary

What is the purpose of this trial?

This trial tests a new imaging dye called 18F-4FN for special scans. It aims to help doctors see inflammation in patients, especially those with immune-related issues. The dye works by sticking to chemicals produced during inflammation, making these areas visible on scans.

Research Team

Lesley Flynt, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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 am 18 years old or older.

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

Exclusion Criteria

I am 18 years old or older.

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.

Timeline

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

Treatment Details

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.

Participant Groups

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+