Phase 3 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 aged 18 or older at the time of joining the study.
• People with a body mass index (a measure of body weight relative to height) of 17 or above.
• People who have been diagnosed with glioblastoma (a type of brain cancer) that has clearly come back, as shown on a contrast-enhanced MRI scan, after having previously received both radiation therapy and temozolomide chemotherapy.
• People who may have had surgery to treat the recurrence, provided they have fully recovered from that surgery before joining the study.
• People whose imaging shows that either at least 80% of the visible tumour was removed during surgery, or that any remaining visible tumour measures 20 cubic centimetres or less.
• People taking steroid medications, provided the dose has been stable or reduced for at least one week before the first planned treatment.
• People who have waited at least 4 weeks since a major surgical procedure, or at least 1 week since a minor procedure or needle biopsy, and have recovered from its effects.
• People who have recovered from the side effects of previous treatments, with specific waiting periods depending on the type of treatment received: at least 4 weeks since an experimental drug or device, at least 4 weeks since chemotherapy, at least 6 weeks since a chemotherapy regimen containing a drug called a nitrosourea (such as Carmustine/BCNU), and at least 12 weeks since completing radiotherapy.
• People with a life expectancy of at least 12 weeks.
• People with a Karnofsky Performance Status score of 70 or above — this is a standard medical scale used to measure how well a person can carry out everyday activities (confirm with trial site).
• People whose blood, kidney, liver, and clotting function test results fall within acceptable ranges as determined by specific blood tests conducted within 2 weeks before the first planned treatment (confirm with trial site for exact values).
• People whose brain tumour is located at least 30 millimetres beneath the skull bone in the area targeted by the focused ultrasound treatment.
• Women who could become pregnant must have a negative pregnancy test within 2 weeks before the first treatment, and both women who could become pregnant and men whose partners could become pregnant must agree to use an approved method of contraception from before the first treatment until at least 6 months after the last treatment.
• People who are willing and able to have an intravenous (IV) line placed for receiving Bevacizumab (a medication used in this trial), and who are willing to have their head either fully or partially shaved before the focused ultrasound treatment, if assigned to the treatment group.
• People, or their legal representatives, who are able to give written consent to take part and who are willing to follow all study procedures, instructions, and requirements for the duration of the trial, including consent for biological samples and scans to be stored for future brain tumour research.

Who may not be able to join:

• People whose MRI scans show the tumour has appeared in multiple separate locations in the brain.
• People who have previously received anti-angiogenic treatments — therapies that target blood vessel growth — including Bevacizumab, or other similar drugs targeting VEGF or its receptors.
• People who have previously had Carmustine wafers (a type of chemotherapy implanted directly in the brain) placed during a repeat operation.
• People who have previously received or are currently undergoing tumour treating fields (TTF) therapy, a treatment that uses electrical fields to target tumour cells.
• People with serious or uncontrolled heart disease, including moderate-to-severe heart failure within the past 12 months, unstable chest pain (angina), a heart attack within the past 6 months, or a cardiac shunt (an abnormal connection between heart chambers or blood vessels).
• People who have had a stroke within the past 6 months (a brief episode known as a transient ischaemic attack, or TIA, may not necessarily exclude someone — confirm with trial site).
• People who have an implanted electronic device, such as a pacemaker, implanted defibrillator, medication pump, cochlear implant, or any electronic device implanted in the brain, or who have metal implants in their body that are not safe for use in an MRI scanner.
• People with poorly controlled high blood pressure, meaning the top number is above 150 mmHg and/or the bottom number is above 100 mmHg even while taking blood pressure medication, within 2 weeks before the first treatment.
• People with a history of blood clotting or bleeding problems, including an inherited bleeding disorder, a history of significant coughing up of blood within the past month, or a blood clot (such as a pulmonary embolism) within the past 3 months.
• People with unstable lung disease or a flare-up of chronic obstructive pulmonary disease (COPD), or any breathing condition serious enough to require hospitalisation or that would interfere with taking part in the study.
• People with a psychiatric illness or personal situation that would make it difficult to follow the study requirements.
• People known to be HIV-positive (note: HIV testing is not required to be considered for this study).
• People who have an active bacterial or fungal infection requiring intravenous antibiotics at the time of joining the study.
• People with a history of active stomach or intestinal ulcers, bowel perforations or fistulas (abnormal openings), or an abscess inside the abdomen within the past 6 months.
• People who have been taking blood-thinning medications (such as warfarin or low-molecular-weight heparin) or anti-platelet medications (such as aspirin) within 1 week before starting treatment.
• People with a known allergy or sensitivity to MRI contrast dye, CT contrast dye, SonoVue® (an ultrasound contrast agent), Bevacizumab, or any of their ingredients.
• People who are pregnant or breastfeeding.
• People who use recreational drugs or have a history of drug addiction.
• People with other serious or uncontrolled medical conditions — such as uncontrolled infection, epilepsy, or diabetes — that could pose safety risks or make it difficult to complete the study.
• People who, in the treating doctor's judgement, have any other condition that could increase risk or affect the accuracy of the study results.

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