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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT03051269
Eligibility Criteria:
Inclusion Criteria:
1. Subject age \> 18 years.
2. Verified cancer in the head and neck region of any histology.
3. At least one tumour lesion should be accessible for electroporation.
4. Performance status WHO \<= 2.
5. Progressive and/or metastatic disease.
6. Expected survival of \> 3 months.
7. A treatment-free interval of more than 4 weeks since chemotherapy or radiation therapy of the treatment area.
8. The subject should have been offered the current standard treatment. If there is no further standard treatment to offer or if the subject does not want to receive the treatments offered, the subject may be included in the trial.
9. The subject should be able to understand the information for participants and be willing and able to comply with hospitalization and the agreed follow-up visits and tests.
10. Platelets ≥ 50 billion/L, INR(international normalized ratio)\> 1.5. Medical correction is allowed, e.g. correction of a high INR using vitamin K.
11. Sexually active men and women who can become pregnant must use adequate contraception during this trial (pill, spiral, injection of prolonged progestin, subdermal implantation, hormone-containing vaginal devices, transdermal patches).
12. Signed informed consent.
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Exclusion Criteria:
Patients should be excluded if they meet just one of the criteria stated below:
1. Symptomatic progression of the subject's cancer disease that requires another intervention.
2. Allergy to constituents of the planned anesthesia.
3. Coagulation disorder that cannot be corrected.
4. Chronic renal dysfunction with creatinine\> 200 mmol/L will trigger a Cr-51-EDTA (Ethylenediaminetetraacetic acid) clearance.
5. Pregnancy or lactation.
6. If participating in other clinical trials involving experimental drugs or involved in a trial within 4 weeks prior to study drug administration.
7. Other disorders investigator finds incompatible with participation in the trial.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03051269
Study Brief:
Protocol Section:
NCT03051269