Adjuvant Temozolomide ± 5-Aminolevulinic Acid + Low Intensity Diffuse Ultrasound Sonodynamic Therapy System for Newly Diagnosed Glioblastoma

Conditions

• GBM
• Glioblastoma

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• 5-ALA HCl + LIDU SDT — COMBINATION_PRODUCT
  standard of care temozolomide + sonosenitizer + sonodynamic therapy
• Placebo + Sham SDT — COMBINATION_PRODUCT
  standard of care temozolomide + placebo + sham sonodynamic therapy

Study Details

The purpose of this research is to test an investigational device using ultrasound along with an investigational drug to see if it is useful in treating glioblastoma following standard of care therapy surgery and chemoradiation. This study is evaluating an experimental treatment for glioblastoma that uses an investigational drug (5-ALA) combined with a non-invasive ultrasound device (LIDU) to target tumor cells. Patients meeting the entry requirements to be in the study, will be equally randomly assigned to receive the study device plus the active study drug plus active ultrasound, or to a "sham" procedure where the ultrasound is not being activated and the study drug is a placebo (looks the same but does not contain active drug). Neither the patient or the investigator will know who is in the active group or not. Both groups will continue to receive the standard therapy of oral Temozolomide.

Key Dates

Start date

Jan 28, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

103 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: (experimental arm)
  * 5-ALA HCl (5-amino-levulenic acid) for oral solution (20 mg/kg) p.o. 6-8 hours prior to LIDU SDT * LIDU SDT System (low intensity diffuse ultrasound sonodynamic therapy), for 40 minutes followed by standard of care TMZ * SOC TMZ to be started Day 2 (+/-1 day) per the approved PI
• Placebo Comparator: Arm B: (placebo arm)
  * Placebo oral solution (matched to 20 mg/kg) p.o. 6-8 hours prior to Sham SDT * Sham SDT for 40 mimnutes followed by standard of care TMZ * SOC TMZ to be started Day 2 (+/-1 day) per the approved PI

Primary Outcome Measure

Evaluate and compare progression-free survival of patients by treatment arm [ Time Frame: Up to 24 months ]

Central Contacts

• Ann-Marie VP, Clinical Operations
  4842521960
  [email protected]

Locations (9)

Find similar trials in Boston, MA

Related Studies

• Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA
  PHASE2 · Recruiting · Northwell Health · New York, New York
• Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
  PHASE1/PHASE2 · Recruiting · Northwell Health · New York, New York
• INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
  PHASE2 · Recruiting · Patrick Wen, MD · Birmingham, Alabama
• Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
  PHASE1/PHASE2 · Recruiting · Northwell Health · New York, New York