TheranosticTrials.org

Clinical Trial · NCT03242993

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

Overview

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)

Sponsor

University of Lausanne Hospitals

Phase

Phase 1

Contacts

John Prior, Prof (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03242993

Drug / Compound

AzaFol

Isotope(s):
Target(s):
  • FR
Ligand Class: Small Molecules

Eligibility

Inclusion

  • FR-negative histology in routinely acquired biopsy samples (6 Patients)
  • Patients with cancer of the ovaries (adenocarcinoma) or non-small cell lung cancer (adenocarcinoma, squameous cell cancer or other histology) having active tumor with an indication for a systemic treatment in first or further line.
  • FR-positive histology in routinely acquired biopsy samples (30 Patients)
  • Last systemic treatment should not applied within 3 weeks before performing study exam

Exclusion

  • other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),
  • women who are pregnant or breast feeding,
  • Enrolment of the investigator, his family members, employees and other dependent persons
  • contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
  • women with the intention to become pregnant during the course of the study,
  • inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,
  • ECOG 3-4
  • Participation in another study with an investigational drug during the present study and 7 days thereafter.
  • known or suspected non-compliance, drug or alcohol abuse,
  • Renal clearance \< 60 mL/min; liver transaminases ≥ 3-fold increased; bilirubin \> 1.5-fold increased; Hb \< 8 g/dl; Tc \< 100'000, ANC \< 1'500/ul