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:

• People with suspected returning glioblastoma (a type of brain tumour) that can be clearly seen and measured on imaging scans, with at least one area of the tumour that shows up with contrast dye, sized between 2 cm³ and 20 cm³
• People whose tumour is located in a part of the brain that surgeons can safely reach, and sits between 30 mm and 90 mm from the inner surface of the skull (so it falls within the range of the treatment device used in this trial)
• People whose tumour recurrence has been confirmed through imaging and reviewed by a specialist medical team
• People aged between 18 and 80 years old at the time of signing consent
• People who have no medical reasons preventing them from having repeat brain surgery
• People with a Karnofsky Performance Score of 70–100, which means they are able to carry out normal activities and care for themselves with little or no assistance (confirm with trial site)
• People who are able to have an MRI scan with contrast dye
• People who are able to swallow tablets or capsules
• People who are willing and able to attend scheduled appointments, follow the treatment plan, and complete required tests and procedures
• People who are able to understand the study and are willing to sign a written consent form (or have a legally authorised representative do so on their behalf)
• People who have had prior chemotherapy, radiation, immunotherapy, or another experimental treatment and have recovered from most of its side effects, except for hair loss or mild nerve-related symptoms
• People whose blood counts, kidney function, and liver function meet the specific levels required by the trial (confirmed through blood tests at the trial site)

Who may not be able to join:

• People with a known allergy or sensitivity to 5-ALA (a medication used in this trial)
• People currently using certain medications that increase sensitivity to light, such as some antibiotics (tetracyclines, sulfonamides, fluoroquinolones) or St John's Wort-type supplements
• People diagnosed with porphyria (a group of disorders affecting the body's production of certain molecules)
• People with a known sensitivity to porphyrins (substances related to the medication used in this trial)
• People who are pregnant
• People with significant heart disease or blood clotting problems
• People who need urgent brain surgery due to dangerous swelling, uncontrollable seizures, or other urgent conditions
• People with an active serious infection, such as a bacterial infection requiring intravenous antibiotics, a fungal infection, HIV, or active hepatitis B or C
• People who have had a mini-stroke (TIA) or stroke within the past 3 months
• People with significant disease affecting major blood vessels (such as an aortic aneurysm)
• People with a known tendency to bleed or problems with blood clotting
• People who need blood-thinning medications that cannot be safely stopped for 7 days before the treatment
• People who have had unstable chest pain or moderate-to-severe heart failure within the past 6 months
• People with severe high blood pressure (systolic at or above 180 mmHg or diastolic at or above 120 mmHg) even when taking blood pressure medications
• People who have had a full heart attack within the past 6 months
• People with a serious, uncontrolled irregular heartbeat
• People experiencing a sudden worsening of a chronic lung condition (such as COPD)
• People with other serious uncontrolled health conditions that the trial doctor believes would make participation unsafe
• People who have taken part in another experimental drug trial or procedure within the past 30 days, or within 5 half-lives of the experimental drug (whichever is longer)
• People with significant brain swelling causing the brain's midline to shift more than 15 mm
• People with evidence of bleeding inside the brain within the past 30 days
• People with calcium deposits or metal implants in the path of the ultrasound device used in this trial
• People with significant thinning of the scalp or scarring at the area where the treatment device would be placed
• People with blood vessel disease affecting the brain or body
• People who require or are currently on dialysis
• People with serious chronic lung conditions (such as severe emphysema, pulmonary vasculitis, or other conditions that significantly reduce lung function)
• People who received radiotherapy within 21 days before joining the trial
• People who received chemotherapy within 21 days before joining the trial
• People who have previously received sonodynamic therapy (the type of treatment being studied in this trial)
• People currently using the Optune device (a type of electrical field therapy for brain tumours)
• People currently taking high-dose antioxidant supplements or certain medications with strong antioxidant effects, including high-dose vitamins C or E, N-acetylcysteine, or certain blood pressure medications such as captopril
• People with a known allergy or sensitivity to gadolinium (a contrast dye used in MRI scans)

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