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NCT ID: NCT03242993 Completed - Clinical trials for Metastatic Ovarian Cancer

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

Start date: April 1, 2017
Phase: Phase 1
Study type: Interventional

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)