A Phase 1 Clinical Trial Evaluating the Safety and Tolerability of Bilateral Hemispheric 5-ALA-Mediated Sonodynamic Therapy Using the LIDU System Before Standard Radiochemotherapy and During Adjuvant Temozolomide in Patients With Histologically Proven Newly Diagnosed Butterfly Glioma

Summary

This study is assessing the safety and tolerability of 5-ALA- mediated Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound, in patients who have just been diagnosed with bihemispheric (in both sides of the brain) glioblastoma, sometimes called butterfly glioblastoma, before they complete their standard of care chemotherapy and radiation and after their standard of care chemotherapy and radiation while they are receviing their standard of care adjuvant chemotherapy.

Eligibility

Age range

18–80 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  5-ALA

  5-ALA is an oral drug that is taken prior to PoMA

• Device
  Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound

  Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound

Location