MR-HIFU for Osteoma

Not currently recruiting at 1 trial location

Overseen By Ann Liew, MS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Children's National Research Institute

Must be taking: Nsaids

Disqualifiers: Serious infections, Hepatic dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called MR-HIFU, which uses focused ultrasound to target and destroy painful bone tumors known as osteoid osteomas (OO). The goal is to determine if this non-invasive procedure is safe and effective for children and young adults with these tumors, especially if other treatments have failed. Participants should have OO that causes pain relieved by certain painkillers and is located in a bone accessible by ultrasound. Those who have had unsuccessful treatments like surgery or other procedures can join. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients on prophylactic anticoagulation (blood thinners) are included, so it might be possible to continue some medications. It's best to discuss your specific medications with the trial team.

What prior data suggests that MR-HIFU treatment is safe for osteoid osteoma?

Research has shown that MR-HIFU, or Magnetic Resonance-guided High-Intensity Focused Ultrasound, safely treats osteoid osteoma, a painful bone tumor. Studies indicate that patients tolerate MR-HIFU well, with a high success rate and a low risk of tumor recurrence. For instance, research on children and young adults found the treatment effective and long-lasting. Another study with nine patients revealed that the treatment did not cause serious side effects. Overall, these findings suggest that MR-HIFU is a safe treatment option for osteoid osteoma. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for osteoid osteoma, which often include radiofrequency ablation (RFA) or surgical removal, MR-guided High-Intensity Focused Ultrasound (MR-HIFU) offers a non-invasive alternative. MR-HIFU is unique because it uses focused ultrasound waves, guided by MRI, to precisely target and ablate the tumor without the need for incisions. Researchers are excited about this treatment because it not only reduces the risk of infection and recovery time associated with surgery but also provides an option for patients who may not respond fully to initial treatments. Plus, the ability to offer a second MR-HIFU procedure if needed can further enhance its effectiveness in managing pain and symptoms.

What evidence suggests that MR-HIFU treatment might be an effective treatment for Osteoid Osteoma?

Research has shown that MR-HIFU (Magnetic Resonance-Guided High-Intensity Focused Ultrasound) effectively treats osteoid osteoma, a painful bone tumor. Studies have found a high success rate and a low chance of recurrence with this treatment. It uses focused sound waves to heat and destroy the tumor, while MRI (Magnetic Resonance Imaging) guides and monitors the process in real time. Early results suggest that MR-HIFU significantly relieves pain, making it a promising option for children and young adults with this condition. ^{2 5 6 7 8}

Who Is on the Research Team?

Karun Sharma, MD, PhD

Principal Investigator

Children's National Research Institute

Are You a Good Fit for This Trial?

This trial is for children and young adults up to 30 years old with painful Osteoid Osteoma, a type of bone tumor. Participants must have pain relieved by NSAIDs and specific imaging findings. They should be healthy enough for anesthesia, not have significant unrelated illnesses or implants that could interfere with treatment, and the tumor shouldn't be too close to sensitive areas like major nerves or organs.

Inclusion Criteria

I am 30 years old or younger.

Location of OO: eligible lesions must be located in a bone with acoustic accessibility and within the normal safety margins of MR-HIFU, as specified in the instructions for use

I don't have trouble breathing at rest and my oxygen level is above 94%.

Exclusion Criteria

I have a lesion in my spine.

My condition involves the area near the growth plate of a bone.

Inability to undergo MRI and/or contraindication for MRI

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MR-HIFU ablation procedure of osteoid osteoma under general anesthesia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for disease status and adverse events following the procedure

12 months

Regular visits as needed

Second Treatment (if needed)

Participants with incomplete or partial response at 28 days after MR-HIFU will be permitted a second MR-HIFU procedure

1 day

1 visit (in-person)

Standard of Care Treatment (if needed)

If there is still incomplete pain relief without medication use by 28 days following the second MR-HIFU treatment, patients will be offered standard of care treatment with RFA

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MR-HIFU treatment

Trial Overview The trial is testing MR-HIFU (Magnetic Resonance-guided High-Intensity Focused Ultrasound) ablation as a safe and effective way to treat painful Osteoid Osteoma in patients who may or may not have had unsuccessful prior treatments such as CT-RFA (Computed Tomography-guided Radiofrequency Ablation) or surgery.

How Is the Trial Designed?

Group I: All patients Experimental Treatment 1 Intervention

Patients will undergo MR-HIFU ablation procedure of OO under general anesthesia. Patients will be monitored for disease status and adverse events for 12 months following procedure. Patients with incomplete or partial response at 28 days after MR-HIFU will be permitted a second MR-HIFU procedure. If there is still incomplete pain relief without medication use by 28 days following the second MR-HIFU treatment, patients will be offered standard of care treatment with RFA and followed for one year.

Who Is Running the Clinical Trial?

Children's National Research Institute

Lead Sponsor

Trials

227

Recruited

258,000+

Published Research Related to This Trial

In a study of 372 women with symptomatic uterine fibroids who underwent MR-HIFU, the overall rate of adverse events (AEs) was low at 8.9%, with no major AEs reported, indicating that MR-HIFU is a safe treatment option.

The only significant risk factor for AEs was the treatment of type II uterine fibroids, suggesting that while MR-HIFU is generally safe, certain types of fibroids may carry a higher risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence of adverse events after magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) therapy in symptomatic uterine fibroids-a retrospective case-control study. Kociuba, J., Łoziński, T., Zgliczyńska, M., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X23003200

Efficacy and safety of magnetic resonance-guided focused ... Magnetic Resonance Guided Focused Ultrasound (MRgFUS) is highly effective in the treatment of osteoid osteoma, with a high success rate and low recurrence rate.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26786890/

Magnetic Resonance-Guided High-Intensity Focused ... The aim of this study was to report our initial experience using magnetic resonance-guided focused ultrasound to treat osteoid osteomas. This retrospective ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02349971

NCT02349971 | Safety and Feasibility of MR-Guided High ... This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid Osteoma lesions in children and young adults. Detailed Description.

4. fda.gov fda.gov/media/181844/download

Sonalleve MR-HIFU (H190003) 2024 PAC Executive ... The study was entitled “Safety and Feasibility of MR-guided High Intensity Focused Ultrasound. (MR-HIFU) ablation of Osteoid Osteoma in Children ...

5. nature.com nature.com/articles/s41598-022-13213-1

A new versatile MR-guided high-intensity focused ... - Nature Magnetic Resonance Imaging (MRI) is considered as the gold standard method for controlling HIFU thermal ablations in real time, thanks to its ...

6. fda.gov fda.gov/media/181667/download

Sonalleve MR-HIFU (H190003) 2024 PAC Executive ... The study was entitled “Safety and Feasibility of MR-guided High Intensity Focused Ultrasound. (MR-HIFU) ablation of Osteoid Osteoma in ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28590796/

Noninvasive Therapy for Osteoid Osteoma: A Prospective ... MR imaging-guided high-intensity focused ultrasound (HIFU) is a safe, effective, and durable treatment option for the management of osteoid osteoma in children ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf19/H190003B.pdf

summary of safety and probable benefit (sspb) The device was studied for the ablation of osteoid osteomas in children, adolescents and young adults with 9 patients recruited and treated.