EUCTR2021-003374-30-IT进行中（未招募）1 期
A pilot study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas. - SONIC-ALA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Criteria Inclusion: CH patients
- •- age between 18-60 years;
- •- both genders;
- •- diagnosis of grade IV lobar glioblastoma with a diameter of less than 5 cm;
- •- diagnosis confirmed with magnetic resonance examination;
- •- no contraindication to the magnetic resonance examination;
- •- no contraindications to surgery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •1. Brain glioblastoma presenting with the following characteristics:
- •¿ Brain edema and/or mass effect that causes midline shift of more than 10 mm
- •¿ Evidence of recent intracranial hemorrhage within the targeted tumor volume
- •¿ Calcifications in the focused ultrasound sonication path (system tools may not
- •tailor the treatment around these calcifications)
- •2. The sonication pathway to the tumor involves either:
- •¿ more than 30% of the skull area traversed by scars, scalp disorders (e.g. eczema),
- •or atrophy of the scalp
- •¿ Clips, shunts, or other metallic implanted objects in the skull or the brain
- •3. Cardiac disease or unstable hemodynamic status including:
- •¿ Documented myocardial infarction within six months of enrolment
- •¿ Unstable angina on medication
- •¿ Congestive heart failure
- •¿ Left ventricular ejection fraction < 50%
- •¿ Right-to-left, bidirectional, or transient right-to-left cardiac shunts
- •¿ History of a hemodynamically unstable cardiac arrythmia
- •¿ Cardiac pacemaker
- •4. Severe hypertension
- •5. Anti-coagulant therapy or medications known to increase risk of hemorrhage within
- •washout period prior to treatment
- •6. History of a bleeding disorder, coagulopathy or with a history of spontaneous tumor
- •7. Abnormal level of platelets (<100000) or INR >1.3
- •8. Cerebral or systemic vasculopathy
- •9. Known allergy sensitivity or contraindications to gadolinium
- •10. Contraindications to MRI such as non-MRI-compatible implanted devices
- •11. Subjects not fitting comfortably into the MRI scanner
- •12. Difficulty lying supine and still for up to 4 hours in the MRI unit or claustrophobia
- •13. Positive pregnancy test (for pre-menopausal women)
- •14. Severely impaired renal function with estimated glomerular filtration rate
- •<30mL/min/1.73m2 and/or on dyalisis
- •15. Respiratory: chronic pulmonary disorders, e.g. severe emphysema, COPD, pulmonary
- •vasculitis, or other causes of reduced pulmonary vascular cross-sectional area.
- •16. Any illness or medical condition that in the investigator’s opinion precludes participation
- •in this study
- •17. Patients unable to sign a consent form
研究者
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