MRgFUS vs. CTgRFA for Bone Tumors

Recruiting at 2 trial locations

Overseen By Maya Aslam

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Matthew Bucknor

Must not be taking: Anti-arrhythmics

Disqualifiers: Pregnancy, Unstable cardiac, Severe hypertension, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, MRgFUS (a type of focused ultrasound therapy) and CTgRFA (a type of radiofrequency ablation), to evaluate their effectiveness in reducing pain from osteoid osteomas, which are painful bone tumors. The researchers aim to determine if MRgFUS matches or surpasses CTgRFA in pain relief, patient comfort, and fewer side effects. Individuals with osteoid osteomas causing pain that disrupts daily life and who have not received previous treatments for the condition might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain relief.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients must have medically uncontrolled pain, which might imply that current pain medications are not effective. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both MRgFUS and CTgRFA are generally safe treatments for bone tumors. MRgFUS, or Magnetic Resonance-guided Focused Ultrasound, effectively and safely reduces pain in individuals with bone metastases and osteoid osteomas. Many studies report that patients tolerate it well without serious side effects.

Similarly, CTgRFA, or Computed Tomography-guided Radiofrequency Ablation, is also considered safe and effective. Research indicates high success rates in pain reduction, with almost all patients experiencing relief. It has been used safely even in young children, demonstrating its reliability.

Both treatments have undergone thorough testing and are usually well-tolerated with minimal safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for bone tumors because they offer innovative approaches to tackling the condition. Magnetic resonance-guided focused ultrasound (MRgFUS) is unique because it uses precise ultrasound waves to heat and destroy tumor tissues, offering a non-invasive option that might reduce recovery time compared to traditional surgeries. Computed tomography-guided radiofrequency ablation (CTgRFA), on the other hand, uses heat generated by radio waves to target and eliminate tumor cells, providing a more targeted approach than some standard treatments that may affect more surrounding tissue. Both methods aim to improve patient outcomes by focusing treatment directly on the tumor, minimizing damage to healthy tissue, and potentially reducing side effects compared to more invasive options.

What evidence suggests that this trial's treatments could be effective for osteoid osteomas?

This trial will compare two treatments for bone tumors: CT-guided radiofrequency ablation (CTgRFA) and magnetic resonance-guided focused ultrasound (MRgFUS). Studies have shown that CTgRFA effectively treats osteoid osteomas, a type of bone tumor, by successfully addressing the condition in all cases and preventing recurrence. Research also indicates that CTgRFA provides long-lasting pain relief and remains safe, even for young children.

Meanwhile, research suggests that MRgFUS effectively relieves pain from bone tumors like osteoid osteomas. Studies highlight its effectiveness and safety for pain relief. As a non-invasive option, MRgFUS may increase patient comfort and reduce post-procedure pain. Both treatments have strong evidence supporting their effectiveness, offering good options for those dealing with osteoid osteomas. ^{2 4 6 7 8}

Who Is on the Research Team?

Matthew Bucknor, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for men and women aged 8 or older with painful, benign bone tumors called osteoid osteomas. Participants must have a confirmed diagnosis, be able to undergo MRI exams and receive anesthesia, have not had previous treatments for the tumor, and suffer from significant pain despite medication.

Inclusion Criteria

I am 8 years old or older.

I have another pain site less severe than my osteoid osteoma pain.

Patients (or guardians/parents) able and willing to give consent and attend all study visits

Exclusion Criteria

Intolerance or allergy to sedation/anesthesia medications or MR contrast agent

I cannot communicate with the research team.

I need surgery to stabilize a bone affected by cancer or to prevent a fracture.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MRgFUS or CTgRFA for the treatment of osteoid osteomas

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain resolution and adverse events

12 months

Multiple visits (in-person and virtual) at 1 week, 2 weeks, 3 weeks, 1 month, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CTgRFA
• MRgFUS

Trial Overview The study compares MR-guided Focused Ultrasound (MRgFUS) with CT-guided Radiofrequency Ablation (CTgRFA) in treating osteoid osteomas. It aims to determine if MRgFUS is as effective as CTgRFA in reducing pain while potentially improving recovery time, patient experience, resource use, and side effects.

How Is the Trial Designed?

Group I: MRgFUS Active Control 1 Intervention

Magnetic resonance-guided focused ultrasound ablation

Group II: CTgRFA Active Control 1 Intervention

Computed tomography-guided radiofrequency ablation

Who Is Running the Clinical Trial?

Matthew Bucknor

Lead Sponsor

Trials

2

Recruited

80+

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Published Research Related to This Trial

In a study of 35 patients with high-grade soft tissue sarcoma, the combination of high-dose recombinant tumor necrosis factor-alpha (rTNF-alpha) and melphalan administered via isolated limb perfusion (ILP) resulted in a remarkable overall response rate of 91%, with 37% achieving complete response.

The treatment led to an impressive limb preservation rate of 85%, indicating its efficacy in managing advanced soft tissue sarcoma while minimizing the need for amputation or extensive surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High dose tumor necrosis factor-alpha and melphalan administered via isolated limb perfusion for advanced limb soft tissue sarcoma results in a >90% response rate and limb preservation. Gutman, M., Inbar, M., Lev-Shlush, D., et al.[2022]

In a study involving 21 patients with malignant melanoma, the combination of recombinant human tumor necrosis factor (rhTNF-alpha) and melphalan delivered through isolated hyperthermic regional perfusion resulted in an 80% overall response rate, with complete tumor regression in 13 patients.

The treatment was generally safe, with manageable side effects and no severe cardiovascular or pulmonary complications, although some patients experienced temporary liver and renal function impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Isolated hyperthermic limb perfusion with melphalan and tumor necrosis factor in malignant melanoma]. Kettelhack, C., Hohenberger, P., Schlag, PM.[2013]

The RGD-FasL fusion protein effectively suppressed tumor growth and improved survival in a murine model of hepatocellular carcinoma (HCC) without causing significant toxicity, such as weight loss or organ failure.

RGD-FasL was found to induce apoptosis more effectively in cancer cell lines compared to standard FasL, suggesting it could be a promising low-toxicity treatment option for cancer that warrants further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RGD-FasL induces apoptosis in hepatocellular carcinoma. Liu, Z., Wang, J., Yin, P., et al.[2021]

A new fusion protein called (RGD)3/tTF was successfully developed and expressed in E. coli, showing the ability to induce blood coagulation and activate Factor X, which is important for blood clotting.

This fusion protein demonstrated a 32% increase in specific binding to the alphavbeta3 receptor compared to the previous version (RGD/tTF), suggesting enhanced targeting capabilities for selectively thrombosing tumor blood vessels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Gene expression and activities analysis of a new fusion protein (RGD) 3/tTF]. Yan, JH., Yang, GW., Wang, JP., et al.[2019]

Intravenous infusion of human recombinant tumor necrosis factor-alpha (rTNF-alpha) did not cause any significant damage to normal brain tissue or alter the blood-brain barrier (BBB) integrity in healthy rats, indicating a good safety profile for normal brain tissue.

In rats with malignant glioma, rTNF-alpha treatment led to significant BBB breakdown and increased tumor necrosis, especially with multiple injections, suggesting that rTNF-alpha may enhance drug delivery and efficacy in treating brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute effects of human recombinant tumor necrosis factor-alpha on the cerebral vasculature of the rat in both normal brain and in an experimental glioma model. Kido, G., Wright, JL., Merchant, RE.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4920061/

Effectiveness of Computed Tomography Guided ... The aim of this retrospective study is to determine our experience of technique success rate, complications and clinical results in long term follow up for CT- ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1076633220300775

Computed Tomography-Guided Radiofrequency Ablation ... CT-guided RFA is a safe and effective procedure in the management of OO in atypical sites with 100% primary success rate, 0% long-term recurrence rate, and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5644327/

CT-guided radiofrequency ablation in osteoid osteoma CT-guided percutaneous RFA is a simple, safe, minimally invasive, and highly effective treatment option for osteoid osteoma with good long-term pain control.

4. mdpi.com mdpi.com/2075-4418/12/11/2812

CT-Guided Radiofrequency Thermal Ablation for the ... CT-guided RFA is effective and safe for the treatment of osteoid osteoma, even in atypical, early onset in children under 4 years of age.

5. ecios.org ecios.org/DOIx.php?id=10.4055/cios19179

The Efficacy of Radiofrequency Ablation for Bone Tumors ... This study aimed to retrospectively analyze the clinical features and survival rates of bone tumors treated with RFA for the past 10 years and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26050823/

Computed tomography-guided radiofrequency ablation is a ... Results: The response rate was 52/60 (87%). Pain relief after the first RFA treatment was found in 46/52 (88%) of the patients and after re-RFA in 51/52 (98 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6819852/

The safety and the efficacy of computed tomography ... The aim of this study was to investigate the efficacy and safety of Computed Tomography (CT) guided percutaneous Radiofrequency Ablation (RFA) in the ...

8. ugeskriftet.dk ugeskriftet.dk/dmj/computed-tomography-guided-radiofrequency-ablation-safe-and-effective-treatment-osteoid-osteoma

Computed tomography-guided radiofrequency ablation is a ... Computed tomography-guided radiofrequency ablation is a safe and effective treatment of osteoid osteoma located outside the spine.