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NCT05630209RECRUITINGIRB Ready

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)

Sponsored by InSightec

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 10 participants interested
10% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.

Who Can Participate

Inclusion Criteria

Age between 5 and 21 years, inclusive. Subjects younger than 5 years old may be eligible after discussion with the Sponsor Medical Monitor/designee (i.e. DSMB).
Patient diagnosed with DIPG
At least 4-week and not greater than 12 weeks from completion of radiation therapy
Post-radiation imaging does not show evidence of necrosis/ hemorrhage or other features that contraindicate MRgFUS
If brain surgery occurred, at least 14 days passed since last brain surgery and the patient is fully recovered and neurologically stable
If on steroids, stable or decreasing dose for at least 7 days prior to study entry
Stable or improving neurologic status for 7 days prior to study entry
Able and willing to give consent and/or assent or have a legal guardian who is able and willing to do so
Able to attend all study visits and with life expectancy of at least 6 months

Exclusion Criteria

Tumor not visible on any pre-therapy or post-radiation imaging
Previous par

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

10 participants

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Age Range

5 Years - 21 Years

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Gender

ALL

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Sponsor

InSightec

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Washington D.C.

District of Columbia

Location available
View Washington D.C. location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Fort Worth

Texas

Location available
View Fort Worth location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for DIPG Treatment in Washington D.C.?

Join others in District of Columbia exploring innovative treatment options through clinical research

DIPG Treatment Options in Washington D.C., District of Columbia

If you're searching for DIPG treatment in Washington D.C., participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Washington D.C., Miami, Fort Worth and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with DIPG. All study-related care is provided at no cost to participants.

Local Sites
3 locations in District of Columbia
Now Enrolling
Up to 10 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for DIPG?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for DIPG

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This DIPG Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05630209. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.