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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Lausanne Hospitals
• Collaborators: Cantonal Hospital of St. Gallen; University Hospital, Zürich
• Treatments: Folic Acid; Vitamin B Complex

Criteria

Inclusion Criteria:

• 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.

• Last systemic treatment should not applied within 3 weeks before performing study exam

• Male and female patients 18 years and older,

• Voluntarily signed Informed Consent after being informed

Inclusion criteria for [18F]-AzaFol PET (enrollment into study):

• FR-positive histology in routinely acquired biopsy samples (30 Patients)

• FR-negative histology in routinely acquired biopsy samples (6 Patients)

Exclusion Criteria:

• contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,

• women who are pregnant or breast feeding,

• women with the intention to become pregnant during the course of the study,

• other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease),

• 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

• ECOG 3-4

• known or suspected non-compliance, drug or alcohol abuse,

• inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the subject,

• Participation in another study with an investigational drug during the present study and 7 days thereafter.

• Enrolment of the investigator, his family members, employees and other dependent persons