Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-25 @ 1:16 AM
NCT ID:
NCT03242993
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03242993
Study Brief:
Protocol Section:
NCT03242993