Sonodynamic Therapy in Patients With Recurrent GBM

Exclusion Criteria

• •1. Known sensitivity or allergy to 5-ALA
• •2. Simultaneous use of other potentially phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts)
• •3. Diagnosis of porphyria
• •4. Hypersensitivity against porphyrins
• •5. Pregnancy
• •6. Significant cardiac disease or coagulopathy
• •7. Herniation / intractable seizure / other clinical indications requiring urgent resection
• •8. Known active systemic bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C (for example, hepatitis B surface antigen positive)
• •9. Have had a recent (≤3 months prior to registration) transient ischemic attack or stroke
• •10. Significant vascular disease (e.g. aortic aneurysm)
• •11. Evidence of bleeding diathesis or coagulopathy
• •12. Need for systemic anticoagulation which cannot be held for 7 days prior to SDT
• •13. Unstable angina and/or congestive heart failure (NYH Class III or Class IV; see section 13.2) within 6 months prior to registration
• •14. Severe hypertension (systolic ≥ 180 mm Hg; diastolic ≥ 120 mm Hg) despite anti-hypertensive medications
• •15. Transmural myocardial infarction within 6 months prior to registration
• •16. Serious and inadequately controlled cardiac arrhythmia
• •17. Acute exacerbation of chronic obstructive pulmonary disease
• •18. Has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study
• •19. Treatment with another investigational drug or investigational procedure within 30 days prior to registration or within 5 half-lives of the investigational product, whichever is longer
• •20. Brain edema and/or mass effect that causes midline shift of more than 15 mm
• •21. Evidence of recent (within 30 days prior to registration) intracranial hemorrhage
• •22. Calcifications or metallic implanted objects in the focused ultrasound sonication path
• •23. Scalp atrophy or scars at the expected location of transducer
• •24. Cerebral or systemic vasculopathy
• •25. Need for or currently on dialysis
• •26. Respiratory: chronic pulmonary disorders (e.g., severe emphysema, COPD, pulmonary vasculitis, or other causes of reduced pulmonary vascular cross-sectional area).
• •27. Receipt of radiotherapy ≤21 days prior to registration
• •28. Receipt of chemotherapy ≤ 21 days prior to registration
• •29. Prior treatment with sonodynamic therapy
• •30. Concurrent use of Optune device
• •31. Concurrent use of supplements or medications with substantial antioxidant effects (including sulfhydryl-containing medications such as captopril or supplements such as N-acetylcysteine, or high doses of vitamins with antioxidant activity such as C or E)
• •32. Known sensitivity to gadolinium