[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging

Summary

This is a clinical trial category C as this is a first in man trial with an unapproved investigational product. Nevertheless the risk is considered low due to the low dose ≤ 10μg. No toxicity effects were observed preclinically at a dose \>1000 -fold the intended dose. Open-labeled, non-blinded, non-placebo controlled, multicenter study. Primary objective: Assessment of biodistribution and FR-specific tumor detection of \[18F\]- AzaFol as a PET imaging agent in patients with FR-positive and FR-negative metastatic cancer of the ovaries or lungs. Secondary objective: Calculation of the effective dose to the patient according to the tissue distribution data of \[18F\]-AzaFol (Dosimetry)

Timeline

Start

2017-04-01

Primary completion

2019-06-01

Completion

2019-06-01

Publications

• Gnesin S, Muller J, Burger IA, Meisel A, Siano M, Fruh M, Choschzick M, Muller C, Schibli R, Ametamey SM, Kaufmann PA, Treyer V, Prior JO, Schaefer N. Radiation dosimetry of 18F-AzaFol: A first in-human use of a folate receptor PET tracer. EJNMMI Res. 2020 Apr 8;10(1):32. doi: 10.1186/s13550-020-00624-2.

Drugs

Indications