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:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT05200650
Eligibility Criteria:
Inclusion Criteria:
1. Male and female aged 18-80 years.
2. Subjects who are willing to comply with study procedures.
3. Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
4. Subjects with a known diagnosis of primary head and neck cancer, with or without metastases.
5. Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
6. Subjects with a measurable tumor by either ultrasound, MRI or CT.
7. Subjects with ECOG performance status of 0 -2.
Exclusion Criteria:
1. Subjects with life expectancy of less than 3 months.
2. Pregnant or breastfeeding women.
3. Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age.
4. Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula.
5. Reduced hepatic function, defined as ASAT, ALAT, bilirubin \> 1.5xULN and PK-INR \> 1.5, or a known medical history of liver cirrhosis or portal hypertension.
6. Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl.
7. Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.
8. Participation in any other clinical trial that included an investigational device or medicinal product.
9. Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05200650
Study Brief:
Protocol Section:
NCT05200650