Sonodynamic Therapy for Brain Cancer
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: Nader Sanai
Must not be taking: Phototoxic substances
Disqualifiers: Infections, Stroke, Cardiac issues, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new treatment that uses sound waves and a special drug to target brain cancer cells. The drug is given in a way that makes the cancer cells more sensitive to the sound waves. The treatment aims to help patients whose brain cancer has returned after previous treatments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, there is a required 14-day period without chemotherapy or radiotherapy before starting the trial. Also, you cannot use other potentially phototoxic substances during the study.
What data supports the effectiveness of the treatment Sonodynamic Therapy for Brain Cancer using MR-Guided Focused Ultrasound device (MRgFUS)?
MR-Guided Focused Ultrasound (MRgFUS) has been shown to be effective in treating various conditions like uterine fibroids, breast cancer, and bone metastases by using focused sound waves to heat and destroy targeted tissue. It is also being explored for brain disorders, offering a noninvasive alternative to traditional surgery.
12345Is MR-Guided Focused Ultrasound (MRgFUS) generally safe for humans?
MR-Guided Focused Ultrasound (MRgFUS) has been studied for safety in treating various conditions like breast cancer, bone tumors, and pain from bone metastases, showing it is generally safe for these uses.
35678How is the Sonodynamic Therapy for Brain Cancer treatment different from other treatments?
This treatment is unique because it uses MR-guided focused ultrasound (MRgFUS) to noninvasively target brain tumors, enhancing the delivery of drugs like SONALA-001 (ALA) by temporarily disrupting the blood-brain barrier, which is a major challenge in treating brain cancer.
12359Eligibility Criteria
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.Inclusion 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.
My blood tests show my organs and bone marrow are working well.
+12 more
Exclusion Criteria
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.
I am currently experiencing a severe worsening of my COPD.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive intravenous ALA followed by sonodynamic therapy (SDT) with MRgFUS
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including radiographic and biological assessments
4-14 days
Multiple visits (in-person)
Long-term Follow-up
Participants are monitored for overall survival and progression-free survival
24 months
Participant Groups
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.
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.
MR-Guided Focused Ultrasound device (MRgFUS) is already approved in United States for the following indications:
🇺🇸 Approved in United States as MRgFUS for:
- Research use in clinical trials for recurrent high-grade glioma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
St. Joseph's Hospital and Medical CenterPhoenix, AZ
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Who Is Running the Clinical Trial?
Nader SanaiLead Sponsor
Barrow Neurological InstituteCollaborator
Ivy Brain Tumor CenterCollaborator
SonALAsense, Inc.Industry Sponsor
InSightecIndustry Sponsor
References
Intracranial applications of magnetic resonance-guided focused ultrasound. [2021]The ability to focus acoustic energy through the intact skull on to targets millimeters in size represents an important milestone in the development of neurotherapeutics. Magnetic resonance-guided focused ultrasound (MRgFUS) is a novel, noninvasive method, which--under real-time imaging and thermographic guidance--can be used to generate focal intracranial thermal ablative lesions and disrupt the blood-brain barrier. An established treatment for bone metastases, uterine fibroids, and breast lesions, MRgFUS has now been proposed as an alternative to open neurosurgical procedures for a wide variety of indications. Studies investigating intracranial MRgFUS range from small animal preclinical experiments to large, late-phase randomized trials that span the clinical spectrum from movement disorders, to vascular, oncologic, and psychiatric applications. We review the principles of MRgFUS and its use for brain-based disorders, and outline future directions for this promising technology.
Development of an MR-guided focused ultrasound (MRgFUS) lesioning approach for small and deep structures in the rat brain. [2023]High-intensity magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive therapy to lesion brain tissue, used clinically in patients and preclinically in several animal models. Challenges with focused ablation in rodent brains can include skull and near-field heating and accurately targeting small and deep brain structures. We overcame these challenges by creating a novel method consisting of a craniectomy skull preparation, a high-frequency transducer (3 MHz) with a small ultrasound focal spot, a transducer positioning system with an added manual adjustment of ∼0.1 mm targeting accuracy, and MR acoustic radiation force imaging for confirmation of focal spot placement.
MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. [2022]Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive thermal ablation technique, shown to be clinically effective in the treatment of uterine fibroids and is being evaluated as a method of thermal ablation of benign and malignant breast tumors. To evaluate the safety and initial efficacy of MRgFUS for the palliation of pain caused by bone metastases, in patients for whom other treatments are either not effective or not feasible.
[Magnetic resonance tomography guided focussed ultrasound surgery (MRgFUS) in tumor therapy--a new noninvasive therapy option]. [2018]The demand for minimal or non-invasive therapies especially in tumor therapy is increasing constantly. High frequency focussed ultrasound represents an effective and safe alternative to established thermoablative procedures. In this article we report the advantages of MR-guidance for focussed ultrasound. We describe first clinical experiences in the treatment of uterine fibroids, breast cancer and fibroadenomas of the breast employing MR-guided focussed ultrasound surgery (MRgFUS). This method offers strong potential in the treatment also of other tumorentities since it provides excellent accuracy. Currently numerous efforts are undertaken to introduce MRgFUS for the therapy of liver or cerebral tumors.
Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. [2022]Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a noninvasive technique that has been shown to coagulate benign and malignant tumors. The purpose of this study was to evaluate MRgFUS safety and effectiveness for the ablation of breast carcinomas.
Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults. [2022]Magnetic resonance-guided focused ultrasound (MRgFUS) is an incisionless procedure capable of thermoablation through the focus of multiple acoustic beams. Although MRgFUS is currently approved for the treatment of tremor in adults, its safety and feasibility profile for intracranial lesions in the pediatric and young adult population remains unknown.
Magnetic resonance guided focused ultrasound for treatment of bone tumors. [2018]Magnetic resonance guided focused ultrasound (MRgFUS) is a new modality in the management of primary and secondary bone tumors. We aimed to investigate the safety, efficacy, and feasibility of using MRgFUS for the treatment of (1) benign bone tumors with the intent of complete tumor ablation, (2) primary malignant bone tumors with the intent to assess its effectiveness in causing tumor necrosis, and (3) metastatic bone disease with the intent of pain relief.
Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation. [2018]Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for liver tumour ablation is a challenging task due to motion caused by breathing and occlusion due the ribcage between the transducer and the tumour. To overcome these challenges, a novel system for liver tumour ablation during free breathing has been designed.
Focused Ultrasound Strategies for Brain Tumor Therapy. [2022]A key challenge in the medical treatment of brain tumors is the limited penetration of most chemotherapeutic agents across the blood-brain barrier (BBB) into the tumor and the infiltrative margin around the tumor. Magnetic resonance-guided focused ultrasound (MRgFUS) is a promising tool to enhance the delivery of chemotherapeutic agents into brain tumors.