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 @ 4:14 AM
Ignite Modification Date:
2025-12-25 @ 4:14 AM
NCT ID:
NCT03250520
Eligibility Criteria:
Inclusion Criteria:
* Histopathological diagnosis or MRI of the brain stem or tumor of recurrent high-grade glioma.
* Indication of palliative surgical treatment by neurosurgery.
* Good general condition, enabling the realization of surgical treatment.
* Scale Lansky \> 20)
* conventional treatment (surgery, radiotherapy, and chemotherapy) failed or not applicable to the patient.
Exclusion Criteria:
* Patients with emerging infectious diseases or fever in the last 72 hours prior to placement of the NPt-Ca.
* Patients whose parents/carers do not authorize expressly the realization of procedure with knowledge of its experimental nature, are not agreed or established their commitment to meet follow-up parameters established by this Protocol.
* Patients with surgical complications prior to placement of the NPt-Ca.
* Patients in which the size and location of the lesion do not allow their surgical approach or an increase in volume by infiltration of the lesion with 3 ml of volume of NPt-Ca.
* Patient whose neurological condition do not allow the implementation of MRI without anesthesia.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
14 Years
Study:
NCT03250520
Study Brief:
Protocol Section:
NCT03250520