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 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03620032
Eligibility Criteria:
Inclusion Criteria:
* Patients from 2 to 21 years old will be eligible
* No previous treatment consented apart from steroids
* Strict eligibility criteria will radiologically-verified DIPG (an intrinsic, pontine-based infiltrative lesion hypointense on T1- and hyperintense on T2-weighted sequences, involving at least 2/3 of the pons)
* symptoms lasting less than 6 months, life expectancy ≥4 weeks; Karnowski/Lansky performance status ≥ 40 %
* no organ dysfunction; no pregnancy or breast-feeding
* Patients undergo baseline cranial MRI with gadolinium, to be repeated if treatment begins more than 2 weeks; spinal MRI due to the occurrence of metastatic cases at diagnosis will also be mandatory
* Written and signed informed consent from parents or legal guardians will be obtained before starting the treatment.
Exclusion Criteria:
* Patients below 2 years or over 21
* Pre-treatment with radio or chemotherapy
* Neurofibromatosis 1
* Non-typical imaging
* Symptoms duration over 6 months, Lansky/Karnowski scores below 40%
* Metastatic disease as shown by MRI
* Organ dysfunction, pregnancy or breast-feeding
* Absence of parents, patient or tutor consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
21 Years
Study:
NCT03620032
Study Brief:
Protocol Section:
NCT03620032