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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Toxicity
Secondary outcome measures
Disease response
Immune Markers
Patient reported outcomes and quality of life measurements
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood clotting tests should be within the normal range.You are currently taking other cancer medications.I am 30 years old or younger.I have a confirmed diagnosis of a specific type of cancer, such as sarcoma or neuroblastoma.I have a lesion in my skull.You cannot have an MRI or there are reasons why it's not safe for you to have an MRI.My cancer is in the bone or very close to it and can be safely targeted with HIFU.You have a solid tumor that can be seen on medical images.My cancer came back or didn't respond to initial treatment, and there are no other cure options.I have followed the specific timelines for my last dose of colony stimulating factors.My blood, kidney, and lung functions meet the required levels.My treatment target is near critical areas like nerves or bladder.My treatment targets are touching the hollow organs inside my body.I have had multiple chemotherapy treatments.I am not receiving any other cancer treatments during and after HIFU.I am 2+ months post my own stem cell transplant or 3+ months post donor stem cell transplant with no major side effects.I cannot stay still for long periods during treatments.I have a serious health condition that could make anesthesia risky for me.I have no lingering side effects from previous cancer treatments.My physical health allows me to perform daily activities.I have an implant, prosthesis, or scar tissue where the HIFU beam will go.I have completed my last dose of chemotherapy, immunotherapy, or radiation at the specified time.
Research Study Groups:
This trial has the following groups:- Group 1: MR-HIFU
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.
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