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High Intensity Focused Ultrasound

MR-guided HIFU for Pediatric Cancer

Phase 1
Waitlist Available
Led By AeRang Kim, MD, PhD
Research Sponsored by AeRang Kim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AGE: ≤ 30 years of age
Target lesion(s) must be located in bone or soft tissue in close proximity to bone and reachable within the normal safety margins of HIFU
Must not have
Lesion in the skull
Target <1 cm from nerve plexus, spinal canal, bladder, bowel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a new cancer treatment is safe and effective for kids, teens, and young adults with cancer that has come back or is resistant to treatment.

Who is the study for?
This trial is for children and young adults up to 30 years old with certain types of solid tumors that have not responded to standard treatments. Participants must be recovered from previous therapies, meet specific health criteria, and have a tumor located in bone or near it that can be targeted by HIFU.
What is being tested?
The study tests the safety and feasibility of using Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) as an ablative therapy on pediatric patients with refractory or relapsed solid tumors.
What are the potential side effects?
Potential side effects are not detailed but may include discomfort from staying still during treatment, risks associated with general anesthesia, and possible tissue damage along the path of the ultrasound beam.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 30 years old or younger.
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My cancer is in the bone or very close to it and can be safely targeted with HIFU.
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My cancer came back or didn't respond to initial treatment, and there are no other cure options.
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My blood, kidney, and lung functions meet the required levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a lesion in my skull.
Select...
My treatment target is near critical areas like nerves or bladder.
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My treatment targets are touching the hollow organs inside my body.
Select...
I cannot stay still for long periods during treatments.
Select...
I have an implant, prosthesis, or scar tissue where the HIFU beam will go.
Select...
I have a serious health condition that could make anesthesia risky for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Toxicity
Secondary study objectives
Disease response
Immune Markers
Patient reported outcomes and quality of life measurements

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: MR-HIFUExperimental Treatment1 Intervention
Magnetic Resonance High Intensity Focused Ultrasound (MR-HIFU) ablative therapy for children with recurrent or relapsed solid tumors.

Find a Location

Who is running the clinical trial?

AeRang KimLead Sponsor
1 Previous Clinical Trials
2 Total Patients Enrolled
AeRang Kim, MD, PhDPrincipal Investigator - Children's National Research Institute
Children's National Research Institute
5 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Magnetic Resonance guided High Intensity Focused Ultrasound (High Intensity Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT02076906 — Phase 1
Desmoid Tumors Research Study Groups: MR-HIFU
Desmoid Tumors Clinical Trial 2023: Magnetic Resonance guided High Intensity Focused Ultrasound Highlights & Side Effects. Trial Name: NCT02076906 — Phase 1
Magnetic Resonance guided High Intensity Focused Ultrasound (High Intensity Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02076906 — Phase 1
~1 spots leftby Nov 2025
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