OncoMatch/Clinical Trials/NCT07862647
TMZ + RT + 5-ALA + LIDU SDT System for Newly Diagnosed Butterfly Glioma
Official title: 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
Is NCT07862647 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including 5-ALA and Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound for glioblastom who grade 4.
Treatment: 5-ALA · Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Performance status
WHO 0–2
Demographics
Prior therapy
Cannot have received: temozolomide plus radiotherapy
Commencing TMZ + RT per SOC before the first SDT treatment
Lab requirements
Blood counts
ANC ≥ 1000 cells/mm3; Platelet count ≥ 50,000 cells/mm3; Hemoglobin ≥ 8 g/dL
Kidney function
Creatinine clearance (CrCl) ≥ 50 mL/min (Cockcroft-Gault equation)
Liver function
AST and ALT ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN if Gilbert's syndrome, or direct bilirubin ≤ 1.5 x ULN)
Adequate bone marrow and organ function, defined by the following laboratory values: ANC ≥ 1000 cells/mm3; Platelet count ≥ 50,000 cells/mm3; Hemoglobin ≥ 8 g/dL; AST and ALT ≤ 2.5 x ULN; total bilirubin ≤ 1.5 x ULN (unless Gilbert's syndrome, then ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN); Creatinine clearance (CrCl) ≥ 50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dent Neurologic Institute · Buffalo, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07862647 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior temozolomide plus radiotherapy disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 wild-type is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 80 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages