Metastatic Ovarian Cancer Clinical Trial
Official title:
Biodistribution, Tumor Detection, and Radiation Dosimentry of [18F]-AZAFOL as POSITRON EMISSION TOMOGRAPHY (PET) Tracer in Folate Receptor Positive Cancer Imaging
Verified date | February 2020 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Completed |
Enrollment | 15 |
Est. completion date | June 1, 2019 |
Est. primary completion date | June 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Lausanne University Hospitals | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne Hospitals | Cantonal Hospital of St. Gallen, University Hospital, Zürich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Potential change of overall staging | TNM staging | day 0 | |
Primary | Lesion detection rate in comparison to SOC (CT and/or MR and/or FDG performed within 4 weeks of PET imaging). | % (percentage) | day 0 | |
Primary | Estimation of gained information using this tracer | uptake yes / no | day 0 | |
Primary | quantitative estimations | SUV values for ROC analysis g/ml | day 0 | |
Primary | General estimation of gained confidence in changing/adapting therapy based on this image | continuous % variable of confidence | day 0 | |
Primary | Available biopsy results can be used as further variables to better assess the performance of [18F]-AzaFol | + / - ( positive or negative) | day 0 | |
Secondary | Calculation of the effective dose to the patient according to the tissue distribution data of [18F]-AzaFol (Dosimetry) | The secondary outcome is the calculated tissue distribution data of [18F]-AzaFol obtained in humans. The effective dose for all organs will be calculated using the OLINDA software (version 1.0). The data will be compared to the estimated data from our preclinical data set. This will provide the radiation dosimetry values as well as quantitative biodistribution over all relevant organs. | day 0 |
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