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 range20 Years
SexALL
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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).
. 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.