Phase 2 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 trial.
• 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 tumour) that has clearly come back, confirmed by a special type of brain scan (MRI with contrast dye), after previously receiving radiation therapy and a chemotherapy drug called temozolomide.
• People who may have had surgery for the returning tumour, as long as they have fully recovered from it before joining the trial.
• People whose brain scans show that at least 80% of the visible tumour was removed during surgery, or that the remaining tumour is no larger than 20 cm³ (a small volume).
• People who are taking steroid medications must have been on a stable or reducing dose for at least one week before the first treatment.
• People who have waited at least 4 weeks since any major surgery or invasive procedure, and have recovered from it; or at least 1 week since any minor surgical procedure or needle biopsy.
• People who have recovered from the side effects of previous treatments, with specific waiting periods: at least 4 weeks since an experimental drug or device; at least 4 weeks since chemotherapy; at least 6 weeks since a specific type of chemotherapy called nitrosoureas (such as Carmustine/BCNU); and at least 12 weeks since finishing radiation therapy.
• People who are expected to live for at least 12 weeks or more.
• People who have a Karnofsky Performance Status score of 70 or above — this is a medical rating scale used by doctors to measure how well a person is able to carry out daily activities (confirm with trial site).
• People whose blood and organ function results fall within required ranges — including blood cell counts, kidney function, liver function, and blood clotting — tested within 2 weeks before the first treatment (confirm with trial site for specific values).
• People whose tumour is located in a specific position relative to the skull, at least 30 mm beneath the bone, as required for the ultrasound treatment used in this trial (confirm with trial site).
• 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 a reliable form 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 medication delivery, and to have their head (either fully or partially) shaved before the ultrasound treatment.
• People, or their legal representatives, who are able to give written consent and who are willing to follow all study procedures and requirements for the full duration of the trial.

Who may not be able to join:

• People whose brain scans show the tumour has appeared in more than one separate area of the brain.
• People who have previously received anti-blood-vessel-growth treatments, including a drug called Bevacizumab (Avastin), or similar drugs that target a protein called VEGF or its receptors.
• People who have previously had Carmustine wafer implants placed in the brain during a repeat operation.
• People who have previously received or are currently receiving a treatment called Tumour Treating Fields (TTF).
• People with serious or uncontrolled heart conditions, including moderate-to-severe heart failure within the past 12 months, unstable chest pain (angina), a heart attack within the past 6 months, or an abnormal connection between the chambers of the heart (cardiac shunt).
• People who have had a stroke (not including a brief, temporary stroke-like episode called a TIA) within the past 6 months.
• People who have an electronic device implanted in their body, such as a pacemaker, implanted defibrillator, medication pump, cochlear implant, or any electronic device implanted in the brain.
• People whose blood pressure has not been adequately controlled by medication within 2 weeks before the first treatment, specifically if their systolic pressure is above 150 mmHg and/or diastolic pressure is above 100 mmHg.
• People with a history or current evidence of certain bleeding or clotting problems, including an inherited tendency to bleed, significant coughing up of blood within the past month, or a blood clot in an artery or vein (such as a pulmonary embolism) within the past 6 months.
• People with unstable lung disease, a flare-up of a chronic lung condition (such as COPD), or another breathing problem serious enough to require hospitalisation or that would prevent participation in the trial.
• People with a psychiatric illness or personal circumstances that would make it difficult to follow the trial's requirements.
• People who are known to be HIV-positive (though HIV testing is not required to apply for the trial).
• People who have an active bacterial or fungal infection currently requiring intravenous antibiotics.
• People with a history of active stomach or intestinal ulcers, tears or holes in the digestive tract, or an abscess inside the abdomen within the past 6 months.
• People who have been taking blood-thinning medications (such as warfarin or heparin) or anti-clotting medications (such as aspirin) within 1 week before starting treatment.
• People with a known allergy or sensitivity to MRI contrast dye, CT contrast dye, or the trial drugs Lumason® or Avastin® (Bevacizumab), or any of their ingredients.
• Women 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 epilepsy, uncontrolled diabetes, or active uncontrolled infection, that could pose safety risks or interfere with the trial.
• People who, in the treating doctor's judgement, have any other condition that could increase risk or affect the trial's results.

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