Radiofrequency Ablation and Bone Augmentation for Spinal Metastases

Overseen By Surgery Clinical Trials Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Pregnant, Breastfeeding, Spine surgery candidates, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 session

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding radiofrequency ablation and bone augmentation (a procedure using heat to kill cancer cells and strengthen bones) to radiotherapy can better assist people with cancer that has spread to their spine. The goal is to determine if this combination reduces complications like fractures or nerve problems compared to radiotherapy alone. Patients with cancer in their spine between the T5 and L5 vertebrae, especially if it causes pain or shows certain features on scans, might be suitable candidates. As an unphased trial, this study provides patients an opportunity to contribute to innovative research that could enhance future cancer treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that radiofrequency ablation and bone augmentation with radiotherapy is safe for treating spinal metastases?

Research has shown that using radiofrequency ablation (RFA) with bone strengthening is safe for treating cancer that has spread to the spine. Studies indicate that RFA effectively reduces pain and has a low complication rate of about 3%, meaning only a few patients experience issues after treatment. Reviews of RFA with bone strengthening suggest it is both safe and effective. This treatment uses heat to destroy cancer cells and a material to strengthen the spine. It helps control tumors and stabilizes the spine, making it a promising option for individuals with spinal cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of radiofrequency ablation and bone augmentation with radiotherapy for spinal metastases because it offers a unique two-step approach. Unlike traditional treatments that primarily rely on radiotherapy alone to shrink tumors and relieve pain, this new method first uses radiofrequency-generated heat to directly destroy cancer cells. It then applies a bone-stabilizing agent to reinforce the spine, potentially improving both tumor control and structural support. This dual-action strategy could enhance pain relief and quality of life for patients, distinguishing it from the standard care options.

What evidence suggests that this trial's treatments could be effective for spinal metastases?

Research has shown that radiofrequency ablation (RFA) combined with bone strengthening effectively reduces pain in patients with cancer that has spread to the spine. Studies have found that this treatment provides significant short-term pain relief and helps stabilize the spine. Some reports even indicate complete pain relief within the first 24 hours after treatment. In this trial, one group of participants will receive a combination of RFA and radiotherapy (RT), which may improve local tumor control and support the spine's structure. Another group will receive radiotherapy alone. This suggests that RFA with RT could be a promising approach to managing pain and preventing further issues in patients with spinal cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Reza Talaie

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with confirmed metastatic T5-L5 spinal disease, who have bone pain or risk of skeletal events. They must meet specific blood and organ function criteria, like a certain neutrophil count and liver enzyme levels.

Inclusion Criteria

My spine cancer is confirmed and affects up to two levels between T5-L5.

My white blood cell count is healthy.

My hemoglobin level is at least 10 g/dL without recent blood transfusions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either radiofrequency ablation and bone augmentation plus radiotherapy or radiotherapy alone

1 session

Follow-up

Participants are monitored for skeletal-related events at 1, 3, 6, 12, and 24 months

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiofrequency Ablation/Bone Augmentation with Radiotherapy
• Radiotherapy alone

Trial Overview The study compares radiofrequency ablation plus bone augmentation with radiotherapy to just radiotherapy in treating spinal metastases. It's designed to see which method better prevents complications like fractures or the need for more treatments.

How Is the Trial Designed?

Group I: Radiofrequency ablation and bone augmentation with radiotherapy Active Control 1 Intervention

Radiofrequency-generated heat to eradicate cancer cells, followed by the application of a bone-stabilizing agent to offer both tumor control and structural reinforcement. Radiotherapy (RT) uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size

Group II: Radiotherapy alone Placebo Group 1 Intervention

ONLY uses high-energy radiation to target and destroy cancer cells, providing notable pain relief and potentially reducing tumor size

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12192184/

Radiofrequency Ablation of Painful Spinal Metastasis Conclusions: This systematic review suggests that RFA is a safe and effective treatment for pain control in patients with spinal metastases. It ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666548424000106

Combination radiofrequency ablation and vertebral cement ... The implementation of RFA in conjunction with VCA for the treatment of spinal metastatic tumors resulted in a significant short-term reduction of pain, with ...

3. mdpi.com mdpi.com/1718-7729/31/9/401

Exploring the Efficacy of Combining Radiofrequency ... Conclusions: The combined treatment of RFA/MWA with VP demonstrates significant pain reduction and local tumor control, with a rapid onset of ...

4. jtss.org jtss.org/articles/is-radiofrequency-ablation-in-conjunction-with-vertebral-augmentation-an-effective-option-in-painful-spinal-metastasis/doi/jtss.galenos.2021.22932

IS RADIOFREQUENCY ABLATION IN CONJUNCTION ... demonstrated that the application of vertebral augmentation with RFA had a 100% pain-relieving effect within the first 24 hours, and they found that the ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8571892/

What is the effectiveness of radiofrequency ablation in the ... Low quality evidence has proven RFA to be safe and effective in reducing pain and disability, especially in the short-term.

6. ajronline.org ajronline.org/doi/10.2214/AJR.20.23494?doi=10.2214/AJR.20.23494

Complications of Percutaneous Radiofrequency Ablation of ... Radiofrequency ablation of spinal osseous metastases is safe with a 3.0% rate of complications. The spinal column is the most common site of osseous metastases ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12130721/

Safety, Efficacy, and Adjacent-level Fracture Risk Following ... With regard to the former, radiofrequency ablation (RFA) is a well-established and safe modality for treating cancer-associated bone pain (5,6).