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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
Participants who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to Day 1. A washout period of at least 14 days is required between last chemotherapy dose and Day 1 (provided the patient did not receive radiotherapy).
Confirmed negative serum pregnancy test (β-hCG) before starting study treatment or participant has had a hysterectomy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
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 belowSelect...
I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve pain.
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I am not pregnant or I have had a hysterectomy.
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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 had surgery for a serious brain tumor and it has gotten worse after standard treatment.
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My cancer recurrence was confirmed by a biopsy or a special MRI scan.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from chemotherapy side effects, except for possible hair loss or mild nerve pain.I can understand and am willing to sign the consent form myself or have someone legally authorized to do so.I have been diagnosed with porphyria.I do not have any active infections requiring IV antibiotics or known viral infections like HIV or active hepatitis B or C.My blood tests show my organs and bone marrow are working well.I am currently experiencing a severe worsening of my COPD.You are allergic to porphyrins.I am not pregnant or I have had a hysterectomy.I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.I had surgery for a serious brain tumor and it has gotten worse after standard treatment.I am a man who can father children and will use effective birth control during and for 1 month after treatment.I do not have a bleeding disorder or blood clotting problem.I have had a stroke or mini-stroke in the last 3 months.My cancer recurrence was confirmed by a biopsy or a special MRI scan.You have taken another experimental drug within the past month or still have it in your system.I am 18 years old or older.I have a serious heart rhythm problem that isn't well-controlled.I have not had unstable angina or heart failure in the last 6 months.My high-grade glioma is at its first recurrence, unmethylated, and I've finished standard therapy without plans for surgery.I can take care of myself but might not be able to do heavy physical work.I had a major heart attack in the last 6 months.I have a tumor that can be measured and is between 6 and 20 cm3 in size.I have a serious blood vessel condition.I am not taking medications that increase sensitivity to light.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A Energy Dose-escalation
- Group 2: Arm B Time-escalation
- Group 3: Arm C ALA Dose-escalation
- Group 4: Arm D MRgFUS alone
- Group 5: Arm E Optimal energy and ALA dose
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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