TMZ + RT + 5-ALA + LIDU SDT System for Newly Diagnosed Butterfly Glioma

Part of paid clinical trials in Buffalo, New York.

Sponsor: Alpheus Medical, Inc.
Study ID: NCT07862647
Phase: PHASE1
Status: Recruiting

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Conditions

Bihemispheric GBM
Butterfly GBM
GBM
Glioblastom WHO Grade 4
Glioblastoma
bGBM

Eligibility Criteria

Sex: ALL
Age: 18 Years - 80 Years
Healthy Volunteers: Not accepted

Interventions

5-ALA — DRUG
5-ALA is an oral drug that is taken prior to PoMA
Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound — DEVICE
Porphyrin Metabolite Activation (PoMA) with LIDU ultrasound

Study Details

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.

Key Dates

First listed: Oct 7, 2026
Start date: Oct 29, 2026
Status verified: Oct 2026
Primary completion: Oct 30, 2027
Completion: Mar 30, 2028

Study Design

Enrollment: 30 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: 5-ALA + LIDU SDT System for newly diagnosed butterfly glioma
Patients with newly diagnosed bihemispheric GBM will receive up to 2 treatments of 5-ALA + PoMA with the LIDU ultrasound device prior to receiving standard chemotherapy radiation treatment. Patients will then complete 6 weeks of SOC chemoradition (CRT). After completion of CRT, patients will receive 4 more treatments, 1 treatment every 28 days, of 5-ALA + PoMA.