Clinical trial · Interventional
[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging
Biodistribution, Tumor Detection, and Radiation Dosimentry of [18F]-AZAFOL as POSITRON EMISSION TOMOGRAPHY (PET) Tracer in Folate Receptor Positive Cancer Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer Lung | — | UNRESOLVED | — |
| Metastatic Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-AzaFol | Drug | — | UNRESOLVED |
| folarell | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment group
- description
- 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
- interventionNames
- Drug: [18F]-AzaFol
- Drug: folarell
Primary outcomes (7)
- measure
- SUV values and volume of tracer uptake of all suspected positive lesions
- timeFrame
- day 0
- description
- SUVmax g/ml SUVmean42% g/ml lesion seen on SOC : mm
- measure
- Potential change of overall staging
- timeFrame
- day 0
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGnesin 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