Assessment of a new PET imaging agent for inflammation detection
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
This study is testing a new imaging agent to see if it can help find inflammation in patients with tumors who have received immune therapy.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05335811 on ClinicalTrials.gov |
What this trial studies
This first-in-human study evaluates the safety, biodistribution, and pharmacokinetics of a novel PET imaging tracer, 18F-4FN, which targets reactive oxygen species to non-invasively quantify inflammation. The study aims to determine how well this tracer can localize to areas of inflammation in patients with solid or liquid tumors who have undergone immune checkpoint inhibitor treatment. Participants will receive an intravenous injection of 18F-4FN, and imaging will be conducted to assess its effectiveness and safety profile. The study also explores whether different imaging time points can enhance the data obtained.
Who should consider this trial
Good fit: Ideal candidates include adults with a histologic diagnosis of solid or liquid tumors who have evidence of or clinical suspicion of immune-related adverse events or inflammation.
Not a fit: Patients who are pregnant, lactating, or have contraindications to the use of 18F-4FN will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new method for accurately imaging inflammation in cancer patients, potentially improving diagnosis and treatment monitoring.
How similar studies have performed: While this approach is novel, similar studies using PET imaging for inflammation detection have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient \>/= 18 years of age. * Patients with histologic diagnosis of solid or liquid tumor treated by ICI with evidence of or clinical suspicion of irAE or patients with suspected inflammation. * Normal range standard renal and liver function tests for age: eGFR \>= 60 mL/min/1.73 m2 Adequate liver function: Bilirubin ≤ the upper limit of normal (ULN) Alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤ the ULN Exclusion Criteria: * Pregnant or lactating women: pregnant women are excluded from this study because the effects of \[18F\]4FN in pregnancy are not known. Urine or serum pregnancy test (female \</= 60 years of age or childbearing potential) within 24 hours of the PET scan. * Subjects with contraindications to the use of \[18F\]4FN including confirmed allergy. * Patients with a body weight of 400 pounds or more, or a BMI which precludes their entry into the bore of the PET/CT scanner, because the hardware is not intended to support that weight. * Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the physician may significantly interfere with study compliance. * Children below the age of 18 are excluded because of the unknown but potential risk of administration of radiopharmaceuticals to minors.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Sanjit Tewari, MD — M.D. Anderson Cancer Center
- Study coordinator: Sanjit Tewari, MD
- Email: sotewari@mdanderson.org
- Phone: (832) 729-1874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.