[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging
Status:
Completed
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
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)
Phase:
Phase 1
Details
Lead Sponsor:
University of Lausanne Hospitals
Collaborators:
Cantonal Hospital of St. Gallen University Hospital, Zürich