Sonodynamic Therapy for Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Nader Sanai, MD

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. ^{1 2 3 4 5}

Is 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. ^{3 5 6 7 8}

How 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. ^{1 2 3 5 9}

Research Team

Nader Sanai, MD

Principal Investigator

St. Joseph's Hospital and Medical Center, Phoenix

Eligibility 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.

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.

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

Treatment Details

Interventions

• MR-Guided Focused Ultrasound device (MRgFUS) (Device)
• SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS) (Combination Product)

Trial Overview 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.

Participant Groups

Group I: Arm E Optimal energy and ALA dose Experimental Treatment 1 Intervention

In Arm E patients will receive treatment at the optimal energy and ALA dose determined form prior Arms.

Group II: Arm D MRgFUS alone Experimental Treatment 1 Intervention

In Arm D, MRgFUS treatment alone will be given at the optimal energy determined from previous Arms.

Group III: Arm C ALA Dose-escalation Experimental Treatment 1 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-escalation Experimental Treatment 1 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-escalation Experimental Treatment 1 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 Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Joseph's Hospital and Medical Center Phoenix, AZ

Who Is Running the Clinical Trial?

Nader Sanai

Lead Sponsor

Trials

11

Recruited

440+

Barrow Neurological Institute

Collaborator

Trials

27

Recruited

7,100+

Ivy Brain Tumor Center

Collaborator

Trials

12

Recruited

910+

SonALAsense, Inc.

Industry Sponsor

Trials

4

Recruited

450+

InSightec

Industry Sponsor

Trials

92

Recruited

3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Findings from Research

Magnetic resonance-guided focused ultrasound (MRgFUS) is a noninvasive technique that can precisely target and treat brain disorders by creating thermal lesions and disrupting the blood-brain barrier, which is a significant advancement in neurotherapeutics.

MRgFUS has been successfully used in various clinical applications, including treating bone metastases and uterine fibroids, and is being explored as a safer alternative to traditional neurosurgery for a range of brain-related conditions, supported by studies from small animal models to large clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracranial applications of magnetic resonance-guided focused ultrasound. Lipsman, N., Mainprize, TG., Schwartz, ML., et al.[2021]

High frequency focused ultrasound (MRgFUS) is a promising non-invasive therapy for treating tumors, showing effectiveness and safety in initial clinical experiences with uterine fibroids, breast cancer, and fibroadenomas.

The use of MRI guidance enhances the precision of focused ultrasound treatments, making it a strong candidate for future applications in other tumor types, including liver and brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography guided focussed ultrasound surgery (MRgFUS) in tumor therapy--a new noninvasive therapy option]. Hengst, SA., Ehrenstein, T., Herzog, H., et al.[2018]

In a study involving 30 women with breast cancer, MRgFUS treatment resulted in an impressive average of 96.9% tumor necrosis, indicating its high effectiveness in ablating breast carcinomas.

The procedure was well tolerated with minimal adverse effects, especially when performed under local anesthesia, suggesting it could be a safe noninvasive alternative to traditional surgical methods like lumpectomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. Furusawa, H., Namba, K., Thomsen, S., et al.[2022]

The novel TRANS-FUSIMO Treatment System (TTS) successfully quantifies key parameters for liver tumor ablation using Magnetic Resonance Guided Focused Ultrasound (MRgFUS), achieving a maximum deviation of only 0.16 seconds from planned sonication duration, which is crucial for safe and effective treatment.

The study demonstrated that the sonication process is consistent across different operators, indicating reliability in the system's performance, which is essential for clinical applications and quality assurance in medical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation. Mihcin, S., Karakitsios, I., Le, N., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intracranial applications of magnetic resonance-guided focused ultrasound. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Development of an MR-guided focused ultrasound (MRgFUS) lesioning approach for small and deep structures in the rat brain. [2023]

3. England pubmed.ncbi.nlm.nih.gov

MR-guided focused ultrasound surgery (MRgFUS) for the palliation of pain in patients with bone metastases--preliminary clinical experience. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[Magnetic resonance tomography guided focussed ultrasound surgery (MRgFUS) in tumor therapy--a new noninvasive therapy option]. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance-guided focused ultrasound surgery of breast cancer: reliability and effectiveness. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Initial experience with magnetic resonance-guided focused ultrasound stereotactic surgery for central brain lesions in young adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance guided focused ultrasound for treatment of bone tumors. [2018]

8. Ireland pubmed.ncbi.nlm.nih.gov

Methodology on quantification of sonication duration for safe application of MR guided focused ultrasound for liver tumour ablation. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Focused Ultrasound Strategies for Brain Tumor Therapy. [2022]