Phase 1 Brain Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been newly diagnosed with a specific type of brain tumour (supratentorial glioblastoma or gliosarcoma) that has certain molecular characteristics (IDH wildtype, MGMT unmethylated) and expresses a protein called EGFR, confirmed by pathology review at UVA.
- People aged 18 to 70 years old at the time of signing the consent form.
- People with a general health and functional ability score of at least 70 on the Karnofsky Performance Scale, meaning they are able to carry out normal activity with only minor assistance at most (confirm with trial site).
- People who are willing and able to sign a written consent form for the trial.
- People who have had maximum surgical removal of their tumour, with very little tumour remaining (2 cm³ or less) as shown on an MRI scan taken shortly after surgery.
- People who are able to communicate during a specific ultrasound-based procedure used in the trial.
- People whose tumour and treatment target area are located away from critical brain regions responsible for essential functions like speech or movement.
- People whose tumour location falls within the treatment range of the NaviFUS device, at least 30 mm from the inner surface of the skull.
- Women who could become pregnant must have a negative blood pregnancy test before joining. Men whose partners could become pregnant must agree to use reliable contraception throughout the trial and for one month after the final treatment infusion.
- People whose organ function (such as liver, kidneys, and blood counts) meets the required levels, tested within 10 days before a blood cell collection procedure called leukapheresis.
Who may not be able to join:
- People who have been diagnosed with another cancer within the past two years, unless it was a certain type of skin cancer that has been treated or an in situ cancer. People currently receiving treatment for any other cancer are also not eligible.
- People whose brain surgery involved only a biopsy — a partial removal or greater is required.
- People whose tumour is located in the cerebellum or brainstem.
- People whose initial MRI shows signs that the cancer has spread along the lining of the brain or spinal cord, or along the inner lining of the brain's fluid spaces.
- People whose cancer has spread to areas outside the brain.
- People with signs of active bleeding inside the skull on imaging.
- People with a known allergic reaction to cetuximab or similar EGFR-targeting antibody medicines.
- People with a known sensitivity to gadolinium contrast dye used in MRI scans.
- People with a known sensitivity to Lumason®, an ultrasound contrast agent used in the procedure.
- People with a blood test result indicating likely hypersensitivity to cetuximab based on an "alpha-gal" antibody test.
- People who experience claustrophobia.
- People who have metal clips, shunts, or other metal objects in their skull or brain that are not compatible with MRI machines.
- People with signs of active bleeding or a condition that affects blood clotting.
- People who are unable to stop taking blood-thinning medications as required by local medical standards.
- People with significant scarring or skin thinning on the scalp in the area where the ultrasound device would be placed.
- People with certain heart-related conditions, including: a heart attack or stroke within the past year; a history of chest pain or heart symptoms requiring medication; reduced heart pumping function (ejection fraction below 45%); or a pacemaker.
- People with signs of heart failure currently requiring medical treatment.
- People with HIV, or active Hepatitis B or Hepatitis C infection.
- People who have received a live vaccine within 30 days before the leukapheresis procedure.
- People who have already received any treatment for their brain tumour other than surgery.
- People who are pregnant or breastfeeding.
- People currently on immune-suppressing medications, with the exception of corticosteroids.
- People with any other medical condition, treatment history, or test result that the treating doctor believes could interfere with the trial or would not be in the person's best interest.
- People who, in the treating doctor's judgement, may not be able to follow the trial requirements reliably.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Camilo Fadul, M.D., University of Virginia
Phone: 434-243-7336
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The safety of this treatment will be evaluated through the number of participants experiencing Grade ≥3 dose-limiting toxicities (DLTs).; The feasibility of this treatment will be determined by the proportion of participants achieving ≥75% of the recommended EGFR BATs dose; Incidence and severity of treatment-emergent adverse events (AEs) based on physical examination, vital signs, laboratory parameters, serum chemistry and hematology; Brain uptake of 89Zr-oxine-labeled EGFR BATs measured by PET standardized uptake values (SUV) with and without LIFU BBB opening
Can't join this trial?
Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.