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Device

Sonodynamic Therapy for Brain Cancer

Phase < 1
Recruiting
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
Recurrence must be confirmed by diagnostic biopsy with local pathology review or contrast-enhanced MRI with positive perfusion.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer treatment that uses sound waves and a light-sensitizing drug. Researchers want to see if it is safe and if it works on brain cancer.

Who is the study for?
This trial is for adults over 18 with high-grade gliomas (brain tumors) that have recurred after standard therapy. Participants must be in relatively good health, not pregnant or breastfeeding, and willing to use effective contraception. They should not have serious bleeding disorders, heart conditions, certain infections, or an inability to undergo MRI.Check my eligibility
What is being tested?
The study tests sonodynamic therapy using MR-guided focused ultrasound (MRgFUS) combined with a drug called ALA on patients with recurrent brain tumors. It's a first-in-human study assessing different energy doses of this treatment for safety and effectiveness.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions to intravenous drugs like ALA such as allergic reactions or photosensitivity. The MRgFUS procedure might cause discomfort or risks associated with exposure to focused ultrasound.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can understand and am willing to sign the consent form myself or have someone legally authorized to do so.
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My cancer recurrence was confirmed by a biopsy or a special MRI scan.
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I had surgery for a serious brain tumor and it has gotten worse after standard treatment.
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I am a man who can father children and will use effective birth control during and for 1 month after treatment.
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I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.
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I am 18 years old or older.
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My high-grade glioma is at its first recurrence, unmethylated, and I've finished standard therapy without plans for surgery.
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I can take care of myself but might not be able to do heavy physical work.
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I have a tumor that can be measured and is between 6 and 20 cm3 in size.
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My blood tests show my organs and bone marrow are working well.
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I am not pregnant or I have had a hysterectomy.
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I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biological changes associated with the sonodynamic therapy
Radiographic evidence of tumor physiological imaging changes associated with SDT in recurrent HGG patients (Arm E)
Secondary outcome measures
Best Overall Response (BOR)
Overall Survival
Performance of MRgFUS
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Arm E Optimal energy and ALA doseExperimental Treatment1 Intervention
In Arm E patients will receive treatment at the optimal energy and ALA dose determined form prior Arms.
Group II: Arm D MRgFUS aloneExperimental Treatment1 Intervention
In Arm D, MRgFUS treatment alone will be given at the optimal energy determined from previous Arms.
Group III: Arm C ALA Dose-escalationExperimental Treatment1 Intervention
In Arm C, the MRgFUS power/energy dose will be fixed based on Arm A MTD/OBD, with the SONALA-001 dose escalation.
Group IV: Arm B Time-escalationExperimental Treatment1 Intervention
In Arm B, the time-escalation cohort, the SONALA-001 and power/energy dose combination will be fixed. Participants will be enrolled into two time cohorts (2 days and 6 days post-SDT).
Group V: Arm A Energy Dose-escalationExperimental Treatment1 Intervention
In Arm A, the dose-escalation cohort, there will be 3 cohorts of ascending MRgFUS power/energy dose combinations with a fixed SONALA-001 dose and fixed surgical time. Arm A will determine the power/energy dose combination for Arm B.

Find a Location

Who is running the clinical trial?

Nader SanaiLead Sponsor
8 Previous Clinical Trials
298 Total Patients Enrolled
Barrow Neurological InstituteOTHER
24 Previous Clinical Trials
7,033 Total Patients Enrolled
Ivy Brain Tumor CenterOTHER
10 Previous Clinical Trials
347 Total Patients Enrolled

Media Library

MR-Guided Focused Ultrasound device (MRgFUS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04559685 — Phase < 1
Brain Tumor Research Study Groups: Arm A Energy Dose-escalation, Arm B Time-escalation, Arm C ALA Dose-escalation, Arm D MRgFUS alone, Arm E Optimal energy and ALA dose
Brain Tumor Clinical Trial 2023: MR-Guided Focused Ultrasound device (MRgFUS) Highlights & Side Effects. Trial Name: NCT04559685 — Phase < 1
MR-Guided Focused Ultrasound device (MRgFUS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04559685 — Phase < 1

Frequently Asked Questions

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

What is the present enrollment rate for this experiment?

"Confirmed. The clinicaltrials.gov database attests that this medical experiment, which was originally advertised on March 15th 2021, is actively recruiting participants. 30 individuals are being sought from a single site."

Answered by AI

Are new participants still being accepted for this research endeavor?

"Current information on clinicaltrials.gov indicates that the enrollment for this trial is ongoing. It was initially posted in mid-March 2021 and revised recently, on March 10th 2022."

Answered by AI
~8 spots leftby Feb 2025