MR-HIFU for Osteoma

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

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

To determine treatment safety and efficacy of MR-HIFU ablation of painful Osteoid Osteoma (OO) in children and young adults.

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.

Is MR-HIFU treatment generally safe for humans?

MR-HIFU treatment has been shown to be safe in humans, with studies on conditions like osteoid osteoma reporting no treatment-related complications and significant improvements in pain and quality of life. ^{1 2 3 4 5}

How does MR-HIFU treatment for osteoma differ from other treatments?

MR-HIFU (magnetic resonance-guided high-intensity focused ultrasound) is unique because it is a non-invasive treatment that uses focused ultrasound waves to target and destroy the tumor without the need for surgery or exposure to radiation, unlike traditional treatments like radiofrequency ablation. ^{1 5 6 7 8}

What data supports the effectiveness of the MR-HIFU treatment for osteoma?

Research shows that MR-HIFU (magnetic resonance-guided high-intensity focused ultrasound) is effective in treating osteoid osteoma, a type of benign bone tumor. In a study, 87% of patients experienced complete pain relief, and their quality of life improved significantly, with no major complications reported. ^{1 4 6 9 10}

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. United States pubmed.ncbi.nlm.nih.gov

Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Magnetic Resonance-Guided High-Intensity Focused Ultrasound Ablation of Osteoid Osteoma: A Case Series Report. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

A Bicentric Propensity Score Matched Study Comparing Percutaneous Computed Tomography-Guided Radiofrequency Ablation to Magnetic Resonance-Guided Focused Ultrasound for the Treatment of Osteoid Osteoma. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Therapy for Osteoid Osteoma: A Prospective Developmental Study with MR Imaging-guided High-Intensity Focused Ultrasound. [2018]

5. Germany pubmed.ncbi.nlm.nih.gov

Radiofrequency ablation versus magnetic resonance guided focused ultrasound surgery for minimally invasive treatment of osteoid osteoma: a propensity score matching study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Pediatric Sarcomas Are Targetable by MR-Guided High Intensity Focused Ultrasound (MR-HIFU): Anatomical Distribution and Radiological Characteristics. [2018]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Technical aspects of osteoid osteoma ablation in children using MR-guided high intensity focussed ultrasound. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Feasibility of volumetric MRI-guided high intensity focused ultrasound (MR-HIFU) for painful bone metastases. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Simulating thermal effects of MR-guided focused ultrasound in cortical bone and its surrounding tissue. [2018]