Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Children and young people aged 5 years old up to (but not including) 18 years old
• People who are able to undergo the trial's sound wave treatment and MRI scans without needing sedation
• People who have been diagnosed with a certain type of cancerous brain tumour located in the upper part of the brain (such as malignant glioma, embryonal tumour including ATRT, or ependymoma)
• People whose brain tumour has come back or continued to grow after at least one course of standard treatment (tumours that have spread to multiple spots are also considered)
• People for whom a medical team has agreed, in a multidisciplinary meeting, that treatment with the chemotherapy drug carboplatin is appropriate
• People with a general health and activity score above 50% on the relevant scale for their age (a lower score caused by movement difficulties from the tumour itself may still be considered)
• People who do not have a dangerous build-up of pressure inside the skull
• People taking steroid medication at a dose of 1mg/kg/day or less
• People whose blood test results show healthy enough levels of white blood cells, platelets, liver function, kidney function, and blood clotting for their age
• People who have no side effects from previous treatments rated at grade 2 or above (confirm with trial site)
• People whose scalp has no unhealed wounds
• People who are covered by health insurance
• Young people aged 15–17 who could become pregnant must have a negative pregnancy test and be using an effective method of contraception
• People (and their parents or legal guardians) who have given written consent to participate

Who may not be able to join:

• People weighing less than 15kg
• People who have significant bleeding inside the tumour, or fluid build-up under the skull on the same side as the tumour
• People who have recently received certain other cancer treatments too close to the start of the trial (specific waiting periods apply depending on the treatment — confirm with trial site)
• People who have had radiotherapy within the last 6 weeks
• People who have been treated for another cancer in the last 5 years
• People who have another serious uncontrolled illness or an active infection
• People with other health conditions that the treating doctor considers would make safe participation difficult
• People whose skull or scalp anatomy (such as skull thickness or very thin skin) could make it unsafe to use the trial device, as judged by the treating doctor
• People who have an implanted heart device (such as a pacemaker or defibrillator), brain stimulator, cochlear implant, or certain metal clips in the brain
• People for whom general anaesthesia is not medically safe
• People for whom MRI scanning is not safe, or who have a known allergy to MRI contrast agents such as gadolinium
• People who have a known allergy or medical condition that makes the use of ultrasound contrast agents unsafe (including certain heart conditions, severe lung blood pressure problems, uncontrolled high blood pressure, or breathing distress — confirm with trial site for the full list)
• People who have a known allergy or hypersensitivity to carboplatin
• People currently being treated with the seizure medications phenytoin or fosphenytoin
• People who have recently received a live attenuated vaccine
• People with significant hearing loss rated at grade 3 or above
• People with a history of problems regulating body temperature
• People for whom regular medical follow-up would not be possible due to geographic, social, or mental health reasons
• People who are pregnant or breastfeeding
• People currently taking blood-thinning medications or drugs that affect platelet function
• People currently taking certain medications that could be harmful to the brain and nervous system if taken within 5 half-lives before the treatment session (including certain sedatives, antihistamines, antipsychotics, and others — confirm with trial site for the full list)
• People taking any other medication that the treating doctor believes could cause brain harm as a result of the trial procedure

Important: Always verify eligibility with the trial site directly before applying.