New combo therapy aims to knock out bone metastasis pain
NCT ID NCT06859801
First seen Jun 24, 2026 · Last updated Aug 20, 2026 · Updated 3 times
Summary
This study is looking at whether combining two treatments — a minimally invasive procedure called percutaneous ablation and standard radiation therapy — can better relieve pain from bone cancer that has spread. Researchers will follow 120 people whose pain is not controlled by medication alone. The goal is to see how well the combo works in real-world settings, measuring pain levels, quality of life, and whether it reduces the need for hospital visits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Percutaneous ablation (a minimally invasive procedure using heat or cold to destroy nerve and tumor tissue) and palliative radiation therapy (targeted X-rays to shrink tumors and relieve pain)
- What this could lead to
- If successful, this combination approach could become a standard way to better control pain and reduce complications from bone metastases, improving quality of life for people with advanced cancer.
- What could go wrong
- This is an observational study, not a controlled experiment, so it cannot prove cause and effect. Results may vary widely among patients, and the procedures carry risks like infection, bleeding, or nerve damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients with previously untreated symptomatic, high-risk skeletal metastases who are scheduled to be treated with percutaneous ablation combined with palliative RT as part of their normal Standard of Care (SOC).
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Skeletal metastasis with localized pain not controlled medically \[recall within last 24 hours of worst pain ≥ 5 using the BPI\] * 2\. Pain must be from one painful metastatic lesion involving the bone (additional less painful metastatic sites may be present). Extra-osseous extension of disease is allowed (must have some contact with the bone and be causing bone/tumor interface pain) * 3\. Lesions that are at high-risk of skeletal related events defined as follows: * a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine * b. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain * 4\. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review * 5\. No prior targeted radiation therapy or ablation to the index lesion * 6\. ECOG performance status 0-2 * 7\. Age ≥ 21 years * 8\. Have signed the current approved informed consent form * 9\. Willing and able to answer follow-up Patient Reported Outcomes (PRO) surveys (e.g., PROMIS®, BPI, COST-FACIT, and OMED) for up to 12 months * 10\. Life expectancy \> 3 months Exclusion Criteria: * 1\. Any medical or personal condition that, in the opinion of the site investigator, may potentially compromise the safety or compliance of the patient, or may preclude the patient's successful completion of the clinical trial. * 2\. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing \> 50% loss of cortical bone \[MIREL Score ≥ 7\] * 3\. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization * 4\. Concurrent participation in other studies that could affect the primary endpoint * 5\. Target tumor causing clinical or imaging evidence of spinal cord compression
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Locations
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Baptist Health Medical Group
RECRUITINGMiami, Florida, 33176, United States
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Emory University Hospital
RECRUITINGAtlanta, Georgia, 30322, United States
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Johns Hopkins Hospital
RECRUITINGBaltimore, Maryland, 21287, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Northside Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
Contact Email: •••••@•••••
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University of California San Diego Moores Cancer Center
RECRUITINGSan Diego, California, 92093, United States
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Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
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