Status:
COMPLETED
[18F]-AZAFOL AS POSITRON EMISSION TOMOGRAPHY (PET) TRACER in FR Positive Cancer Imaging
Lead Sponsor:
University of Lausanne Hospitals
Collaborating Sponsors:
University Hospital, Zürich
Cantonal Hospital of St. Gallen
Conditions:
Metastatic Cancer Lung
Metastatic Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
Human research study using a radiopharmaceutical product to reveal folate receptor (FR) expression in tumors in patients. It is known that the FR is overexpressed on a variety of tumor types. FR-posi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03242993
Start Date
April 1 2017
End Date
June 1 2019
Last Update
February 28 2020
Active Locations (1)
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1
Lausanne University Hospitals
Lausanne, Canton of Vaud, Switzerland, 1011