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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT06678867
Eligibility Criteria:
Inclusion Criteria:
* Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour
* Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours
* Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement
* 3 - 18 years inclusive
* Adequate liver and kidney function
* creatinine - less than one and a half times the upper limit of normal.
* haemoglobin above the lower limit of normal
* Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal
* bilirubin lower than one and a half times the upper limit of normal
* Normal Coagulation profile
o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits
* Urine porphyrin - Test to be completed and sent for analysis
* Blood pressure lower than or equal to the upper limit of normal
* Negative pregnancy test in women of childbearing potential\*
* Informed Consent \*A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient
Exclusion Criteria:
* Patients with low grade tumours (either radiological or histological diagnosis)
* Patient is appropriate for biopsy only, based on Investigator and MDT judgement
* Known history (including family history) of porphyria
* Hypersensitivity to the active substance or to porphyrins
* History of light sensitivity reactions
* Pregnant or breastfeeding women
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT06678867
Study Brief:
Protocol Section:
NCT06678867