MR-HIFU treatment for Osteoma

Children's National Hospital, Washington, United States
OsteomaMR-HIFU treatment - Device
Eligibility
No minimum age - 30
All Sexes

Study Summary

This trial is testing whether MR-HIFU ablation is a safe and effective treatment for Osteoid Osteoma, a painful bone condition, in children and young adults.

Eligible Conditions
  • Osteoma

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Study Objectives

6 Primary · 3 Secondary · Reporting Duration: 12 months

12 months
Number of participants with change in nidus size (mm) as assessed via MRI
Number of participants with change in nidus vascularity as assessed via MRI
Edema
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v.5
Pain relief as assessed by pain medication usage
Pain
Pain relief as assessed using the Visual Analog Scale (VAS)
Quality of life as assessed by using the Pediatric Quality of Life Inventory (PedsQL) v4.0
Quality of life as assessed by using the Symptom Distress Scale (SDS)

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Sonovein Treatment
1
Northera™ (Droxidopa) (Treatment A)
2
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

All patients
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: MR-HIFU treatment · No Placebo Group · Phase 2

All patients
Device
Experimental Group · 1 Intervention: MR-HIFU treatment · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Children's National Research InstituteLead Sponsor
195 Previous Clinical Trials
206,448 Total Patients Enrolled
1 Trials studying Osteoma
9 Patients Enrolled for Osteoma
Karun Sharma, MD, PhDPrincipal Investigator - Children's National Research Institute
Children's National Research Institute
1 Previous Clinical Trials
9 Total Patients Enrolled
1 Trials studying Osteoma
9 Patients Enrolled for Osteoma

Eligibility Criteria

Age No minimum age - 30 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have already received treatment for your condition, but it was not successful.
References

Frequently Asked Questions

Is there a risk in using MR-HIFU to treat patients?

"While there is some data indicating that MR-HIFU treatment is safe, as this is only a Phase 2 trial, there is not yet any evidence to support its efficacy. Consequently, our team has given it a score of 2." - Anonymous Online Contributor

Unverified Answer

How many people have signed up to participate in this clinical trial?

"That is correct. The listing on clinicaltrials.gov indicates that the research team is currently looking for 30 individuals to participate in this trial at a single site. This study was first made public on January 28th, 2021 and has since been updated on November 8th, 2022." - Anonymous Online Contributor

Unverified Answer

Are there any specific requirements to take part in this clinical trial?

"We are looking for 30 osteoma or osteoid patients that meet the following age criteria: 0-30 years old. It is essential that potential participants also fit the following descriptions: less than 18 years old must have a legal guardian present during recruitment, prior unsuccessful treatments including but not limited to CT-RFA and/or surgical resection." - Anonymous Online Contributor

Unverified Answer

Does this study involve elderly patients?

"This particular medical trial is seeking patients aged 0-30. There are other research programs available for children and elderly patients." - Anonymous Online Contributor

Unverified Answer

Are we currently enrolling people for this research project?

"The study, which was originally found on clinicaltrials.gov on 1/28/2021, is still recruiting patients and looking for more volunteers." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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