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

Trial Summary

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.

How does the treatment MRgFUS differ from other treatments for bone tumors?

MRgFUS (Magnetic Resonance-guided Focused Ultrasound Surgery) is unique because it uses focused ultrasound waves to heat and destroy tumor tissue, guided by MRI imaging for precision. This non-invasive approach contrasts with traditional surgical methods, offering a potentially less painful and quicker recovery option for patients. ^{1 2 3 4 5}

What is the purpose of this trial?

Osteoid osteomas are painful, benign bone tumors that occur most frequently in young males between ages 10 and 20 years. The goal of the proposed study is based on the premise that MRgFUS is noninferior to CT-guided radiofrequency ablation (CTgRFA), in terms of pain reduction following treatment of osteoid osteomas, and offers possible improvements with regards to 1) post-procedural pain, 2) clinical resource utilization, 3) patient experience, and/or 4) adverse events. The data from the current study would provide clinicians important information in deciding between treatment options for ablation of osteoid osteomas.

Research Team

Matthew Bucknor, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Isolated hyperthermic limb perfusion with melphalan and tumor necrosis factor in malignant melanoma]. [2013]

2. China pubmed.ncbi.nlm.nih.gov

RGD-FasL induces apoptosis in hepatocellular carcinoma. [2021]

3. China pubmed.ncbi.nlm.nih.gov

[Gene expression and activities analysis of a new fusion protein (RGD) 3/tTF]. [2019]

4. United States 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. [2019]

5. United States 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. [2022]