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Sonodynamic Therapy for Glioblastoma (GBM 001 Trial)

Phase 1
Recruiting
Research Sponsored by Shayan Moosa, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The tumor lesion needs to comprise at least 1 contrast-enhancing lesion with a volume of ≥ 6 cm3 and ≤ 20 cm3 of targeted treatment area
No contraindication to repeat brain surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day after sdt (day 1) up to the time of surgery (day 7-day 21)
Awards & highlights

GBM 001 Trial Summary

This trial will explore if combining a drug with focused ultrasound can reduce GBM tumor cells with less damage to healthy cells.

Who is the study for?
This trial is for adults aged 18-80 with recurrent glioblastoma, a type of brain tumor. Participants must have a specific size and location of the tumor that's accessible for surgery, no recent strokes or severe heart conditions, and be able to swallow pills. They should not be pregnant, have metal in their body that interferes with ultrasound, or have taken certain treatments recently.Check my eligibility
What is being tested?
The study tests sonodynamic therapy (SDT) using an investigational drug called 5-ALA combined with low-intensity focused ultrasound on patients before surgery. SDT aims to non-invasively target and damage tumor cells while sparing normal tissue.See study design
What are the potential side effects?
Potential side effects may include skin sensitivity due to 5-ALA (as it makes skin more sensitive to light), reactions at the site where ultrasound is applied, headache or bleeding from the surgical procedure following SDT. Allergic reactions to any component are also possible.

GBM 001 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is between 6 and 20 cm3 in size and shows up on contrast imaging.
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I can safely undergo another brain surgery.
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I have recovered from previous cancer treatments, except for possible hair loss or mild nerve damage.
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My brain tumor has grown back and can be measured.
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My brain tumor is in a place where surgery can reach it.
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I am mostly able to care for myself and carry out daily activities.
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My brain tumor is within 30 to 80 mm from the inner skull, suitable for NaviFUS treatment.

GBM 001 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day after sdt (day 1) up to the time of surgery (day 7-day 21)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day after sdt (day 1) up to the time of surgery (day 7-day 21) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to have participants undergo planned surgery without delay
Extent of targeted tumor area receiving FUS
Incidence of adverse events
+2 more
Secondary outcome measures
Histologic tumor devitalization
Response of target tissue following SDT on imaging

GBM 001 Trial Design

1Treatment groups
Experimental Treatment
Group I: Sonodynamic Therapy (5-ALA + LIFU)Experimental Treatment1 Intervention
Administration of SDT occurs 1-3 weeks prior to GBM resection

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Who is running the clinical trial?

Shayan Moosa, MDLead Sponsor
~7 spots leftby Dec 2025
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