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

NCT03242993 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-02-28

No results posted yet for this study

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)

Conditions

  • Metastatic Cancer Lung
  • Metastatic Ovarian Cancer

Interventions

DRUG

[18F]-AzaFol

\[18F\]-AzaFol is a radiotracer produced at ETH Hönggerberg in a radiopharmaceutical GMP facility. The drug product is provided as sterile solution for intravenous injection in a glass vial containing 6 mL of formulated product, the maximal applicable dose being 600 MBq.

DRUG

folarell

For the purpose of this study only 1 mg folic acid (corresponding to 0.2 mL Folarell®) will be injected 5 min prior to \[18F\]-AzaFol. Due to this low dose of a single injection of folic acid it is unlikely that adverse events would occur. Folarell® is a folic acid preparation for intravenous or intramuscular injection

Sponsors & Collaborators

  • University Hospital, Zürich

    collaborator OTHER

  • Cantonal Hospital of St. Gallen

    collaborator OTHER

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • John Prior, Prof · Lausanne University Hospitals

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-06-01
Completion
2019-06-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03242993 on ClinicalTrials.gov