Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradia… (NCT04988750) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Safety and Preliminary Efficacy of the Combination of NaviFUS System With Re-irradiation for rGBM Patients
Taiwan7 participantsStarted 2021-05-23
Plain-language summary
This is an open label, single arm, prospective, and pilot study. Eligible patients will be enrolled after acquiring the signed informed consent and then will receive the treatment of re-RT combined with FUS (FUS + re-RT) on an outpatient basis. The re-RT in FUS + re-RT treatment will include fractioned stereotactic radiosurgery (SRS) treatment (FUS + SRS) or conventional radiotherapy (cRT) treatment (FUS + cRT). The treatment of SRS or cRT treatment given to patients is determined by the investigator depending on the volume and location of the treatment region.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male/female patients ≥ 20 years of age.
. Patients who meet one of the following criteria are considered eligible: (1) Histologically proven Grade IV glioma patients that is recurrent following standard radiation therapy (RT) and temozolomide and the second recurrent after prior treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab) administration (bevacizumab failure).
. 4 weeks since last cytotoxic therapy or inhibitor of VEGF or VEGFR (e.g., bevacizumab)
. 6 weeks since the completion of a nitrosourea-containing chemotherapy regimen (e.g., carmustine \[BCNU\])
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined the NaviFUS System with re-irradiation for recurrent glioblastoma — since it's now completed, has any safety or efficacy data been published that you could walk me through, so I understand what was actually found?
2The trial was listed as Phase NA, which suggests it was an early feasibility or device study — what does that mean for how much we actually know about whether this approach is safe or effective compared to more established re-treatment options?
3The primary thing this trial was measuring was adverse events, meaning it was mainly focused on safety rather than proving the treatment works — given that, how would you weigh this approach against standard re-treatment options for recurrent glioblastoma in my specific situation?
4Re-irradiation carries its own risks for brain tissue, and this trial added a focused ultrasound device on top of that — based on what's been reported so far, what kinds of side effects should I be most concerned about discussing if this combination were ever considered for me?
5Since this trial is completed and was studying recurrent high-grade glioma including WHO Grade III-IV tumors, do my tumor's specific grade and molecular profile make this kind of approach something worth exploring, or are there other trials or treatments that might be a better fit right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias.
. Patients with meningeal metastasis, intracranial stroke within the previous 6 months, congestive heart failure, unstable angina, cardiac arrhythmia, unstable cardiac status, and uncontrolled seizure activity.
. Patients with known HIV, however, that HIV testing is not required for entry into this study.
. Any patient requiring supplemental oxygen therapy.
. Use of any recreational drugs or history of drug addiction.
. Pregnant or breast-feeding women.
. The receipt of an investigational drug within a period of 28 days prior to the first FUS exposure.
. Known sensitivity/allergy to PET tracers, O-(2- \[18F\]fluoroethyl)- L-tyrosine (FET) or 2-Deoxy-2-\[18F\]fluoro-D-glucose (FDG); Magnetic Resonance Imaging (MRI) contrast agents, Dotarem; Computer Tomography (CT) contrast agents; SonoVue®; or any of its components.