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

NCT03242993 | Completed Phase 1 DMC

• 1 other identifier: PET - FOL - I
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (7)

• SUV values and volume of tracer uptake of all suspected positive lesions

  SUVmax g/ml SUVmean42% g/ml lesion seen on SOC : mm

  day 0

• Potential change of overall staging

  TNM staging

  day 0

• Lesion detection rate in comparison to SOC (CT and/or MR and/or FDG performed within 4 weeks of PET imaging).

  % (percentage)

  day 0

• Estimation of gained information using this tracer

  uptake yes / no

  day 0

• quantitative estimations

  SUV values for ROC analysis g/ml

  day 0

• General estimation of gained confidence in changing/adapting therapy based on this image

  continuous % variable of confidence

  day 0

• Available biopsy results can be used as further variables to better assess the performance of [18F]-AzaFol

  \+ / - ( positive or negative)

  day 0

Secondary Outcomes (1)

• Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-AzaFol (Dosimetry)

  day 0

Study Arms (1)

treatment group

EXPERIMENTAL

all patients successfully enrolled will be assigned to the treatment group: 1 mg folic acid (corresponding to 0.2 mL Folarell®) will be injected 5 min prior to \[18F\]-AzaFol

Drug: [18F]-AzaFol; Drug: folarell

Interventions

[18F]-AzaFol DRUG

\[18F\]-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.

treatment group

folarell DRUG

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

Also known as: folic acid

treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• FR-positive histology in routinely acquired biopsy samples (30 Patients)
• FR-negative histology in routinely acquired biopsy samples (6 Patients)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• University Hospital, Zürich: collaborator
• Cantonal Hospital of St. Gallen: collaborator

Study Sites (1)

Lausanne University Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Gnesin S, Muller J, Burger IA, Meisel A, Siano M, Fruh M, Choschzick M, Muller C, Schibli R, Ametamey SM, Kaufmann PA, Treyer V, Prior JO, Schaefer N. Radiation dosimetry of 18F-AzaFol: A first in-human use of a folate receptor PET tracer. EJNMMI Res. 2020 Apr 8;10(1):32. doi: 10.1186/s13550-020-00624-2.

  PMID: 32270313 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Ovarian Neoplasms

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John Prior, Prof

  Lausanne University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: This is a single arm study. No placebo or other comparator will be used. \[18F\]-AzaFol is used as a PET tracer, all patients successfully enrolled will be assigned to the treatment group.

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: August 8, 2017
• Study Start: April 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

CH (1)