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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

Find a Location

Who is running the clinical trial?

Shayan Moosa, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals below the age of 55 qualified to participate in this trial?

"According to the criteria for inclusion, participants must be at least 18 years old and no older than 80."

Answered by AI

Has the FDA sanctioned Sonodynamic Therapy (5-ALA + LIFU) for use?

"Due to the nature of a Phase 1 trial, with limited evidence on safety and efficacy, our team at Power rated Sonodynamic Therapy (5-ALA + LIFU) as a 1."

Answered by AI

Do I fulfill the criteria necessary for enrollment in this medical test?

"This clinical trial is seeking 11 glioblastoma patients aged between 18-80 to participate."

Answered by AI

Are enrollment opportunities available for this investigation?

"Currently, this clinical investigation is not recruiting participants. It was originally posted on October 1st 2023 and the data was last updated on September 10th 2023. However, there are an abundance of other medical trials actively searching for patients with 1426 studies presently looking for candidates."

Answered by AI

Who else is applying?

What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Hoping for treatment that will help improve my glioblastoma.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Sonodynamic Therapy in Patients With Recurrent GBM
Shayan Moosa, MD 2024. "Sonodynamic Therapy in Patients With Recurrent GBM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039709.
~7 spots leftby Dec 2025
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