Status:
RECRUITING
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F-Fluoro-1-Naphthol (18F-4FN) for PET Imaging
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Endocrine Neoplasia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
18F-4FN represents a novel PET agent for imaging inflammation. Acute inflammatory signaling through the TLR axis recruits neutrophils and macrophages to inflammatory sites. Both cells activate the pro...
Detailed Description
OBJECTIVES: Primary Objective: The primary objective of this first-in-human (FIH) study is to determine the safety, biodistribution, and dosimetry profile of a novel positron emission tomography (PE...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05335811
Start Date
October 6 2022
End Date
August 31 2026
Last Update
October 14 2025
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030