Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients (NCT04446416) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of NaviFUS System add-on Bevacizumab (BEV) in Recurrent GBM Patients
Taiwan6 participantsStarted 2020-07-21
Plain-language summary
This is a prospective, single-arm, two stages, open-label, pilot study to investigate the efficacy and safety of FUS add-on bevacizumab (BEV) in rGBM patients. The BEV is the best physician's choice of standard of care for rGBM after prior radiotherapy and temozolomide chemotherapy in the LinKou Chang Gung Memorial Hospital. Eligible patients will be enrolled through the process of informed consent.
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 with histologically confirmed glioblastoma, recurrent after prior radiotherapy and temozolomide chemotherapy.
. Patient may have been operated for recurrence. If operated: with measurable residual tumor
. Minimum interval since completion of radiation treatment is 12 weeks
. Patients if already on the steroids then should be on a stable dose of steroids for at least 7 days prior to study treatment
. Body mass index (BMI) ≥17 kg / m2
. Minimum interval since last drug therapy:
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 who have had previous treatment with an inhibitor of vascular endothelial growth factor (VEGF) or VEGFR (including bevacizumab)
. New York Heart Association (NYHA) Grade II or greater congestive heart failure requiring hospitalization within 12 months prior to screening
. Severe hypertension at screening (diastolic blood pressure \> 100 mmHg on medication)
. Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, severe cerebral or myocardial infarction, cardiac shunt, heart attack within the previous 12 months, stroke (except for transient ischemic attack; TIA) within the previous 6 months, or psychiatric illness/social situations that would limit compliance with study requirements
. Unstable pulmonary disease or Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening
. Implanted pacemaker, defibrillator or deep brain stimulator, other implanted electronic devices in the brain or documented clinically significant arrhythmias
. Major surgery such as intra-thoracic, intra-abdominal or intra-pelvic (with the exception of craniotomy), open biopsy or significant traumatic injury ≤ 4 weeks prior to screening, or patients who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 1 week prior to screening, or who have not recovered from side effects of such procedure or injury
. Known HIV positive patients, however, that HIV testing is not required for entry into this study