Bone Cancer MetastaticTRIBUTENCT06859801
A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
An observational study of Bone Cancer Metastatic, run by Society of Interventional Oncology at 8 sites in United States.
Trial summary
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Bone Cancer Metastatic
- What is being tested?
- Percutaneous Ablation and Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 120 participants
- Where
- 8 sitesUnited States
- Study dates
- 23 Oct 2025to 31 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Maria Rivas, 404-712-7962, mrivas2@emory.edu
Junjian Huang, MD
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Shannon Gleason, 404-303-3355, clinical.trials@northside.com
Jason Levy, MD
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Mehreen Nabi, 410-502-0736, mnabi1@jh.edu
Majid Khan, MD
- Recruiting
Baptist Health Medical Group
Miami, Florida, 33176
Jetsenea Coto, 786-596-7708, jetseneac@baptisthealth.net
Gina Landinez, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kyersten Hoene, 9209796340, khoene@mcw.edu
Matthew Scheidt, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Desirae Howe-Clayton, 507-255-0111, Howe.desirae@mayo.edu
Brian Welch, MD
- Recruiting
University of California San Diego Moores Cancer Center
San Diego, California, 92093
Kathy Velasco, 858-822-5677, kcvelasco@health.ucsd.edu
Anthony Tadros, MD
- Recruiting
Washington University
St Louis, Missouri, 63110
Addie Lovato, 314-362-4263, lovato@wustl.edu
Resten Imaoka, MD
About this study
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).
- Conditions
- Bone Cancer Metastatic
- Being tested
- Percutaneous Ablation, Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous AblationDevice
Percutaneous ablation is a minimally invasive alternative therapy for metastatic bone disease and can be used for destruction of nerves mediating pain signals, tumor destruction, decompression, or inhibition of tumor growth.
Radiation TherapyRadiation
Radiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Response
Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE).
- Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain.
- Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start23 Oct 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Cancer MetastaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Society of Interventional Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859801
- Sponsor's protocol ID
- SIO-2025-01
- Acronym
- TRIBUTE
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy
- ClinicalTrials.gov ID
- NCT06859801
- Acronym / sponsor ID
- TRIBUTE / SIO-2025-01
- Conditions
- Bone Cancer Metastatic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Society of Interventional OncologyUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate real-world outcomes (e.g., pain, patient reported outcomes, skeletal related events, healthcare utilization, etc.) in patients treated with both percutaneous ablation and palliative radiation therapy (RT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous AblationPercutaneous ablation is a minimally invasive alternative therapy for metastatic bone disease and can be used for destruction of nerves mediating pain signals, tumor destruction, decompression, or inhibition of tumor growth. | Device | – |
| Radiation TherapyRadiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients. | Radiation | – |
Primary outcome
Pain Response
Time frame: 3 Months
Combined partial and complete pain response rate using the Brief Pain Inventory (BPI), worst pain 24-hour recall, at 3 months following percutaneous ablation and palliative RT as defined by International Consensus on Palliative Radiotherapy Endpoints in clinical trials (ICPRE). • Partial response is defined as pain reduction of 2 or more at the treated site on a scale of 0 to 10 scale without analgesic increase, or analgesic reduction of 25% or more from Baseline without an increase in pain. • Complete response is defined as a pain score of 0 at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily OMED).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of California San Diego Moores Cancer Center
San Diego, United States
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Cancer Metastatic, run by Society of Interventional Oncology at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Response (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.