Recruiting

Ablation & Radiation Therapy

Sponsor:

Society of Interventional Oncology

Code:

NCT06859801

Conditions

Bone Cancer Metastatic

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Percutaneous Ablation

Radiation Therapy

Study Details

Brief 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).

Conditions

Bone Cancer Metastatic

Study ID

NCT06859801

Start date

Oct 23, 2025

Status verified date

Aug, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Interventions

Percutaneous Ablation

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 Therapy

Radiation therapy (RT) is a widely accepted treatment for painful bone metastases and provides palliation of pain for patients.

Primary outcome measure

  • Pain Response [ Time Frame: 3 Months ]

Central Contacts and Locations

Locations

University of California San Diego Moores Cancer Center

Recruiting

San Diego, California, United States, 92093

Contacts

Kathy Velasco

858-822-5677kcvelasco@health.ucsd.edu

Principal Investigator:

Anthony Tadros, MD

Baptist Health Medical Group

Recruiting

Miami, Florida, United States, 33176

Contacts

Jetsenea Coto

786-596-7708jetseneac@baptisthealth.net

Principal Investigator:

Gina Landinez, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Maria Rivas

404-712-7962mrivas2@emory.edu

Principal Investigator:

Junjian Huang, MD

Northside Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Shannon Gleason

404-303-3355clinical.trials@northside.com

Principal Investigator:

Jason Levy, MD

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Mehreen Nabi

410-502-0736mnabi1@jh.edu

Principal Investigator:

Majid Khan, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Desirae Howe-Clayton

507-255-0111Howe.desirae@mayo.edu

Principal Investigator:

Brian Welch, MD

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Addie Lovato

314-362-4263lovato@wustl.edu

Principal Investigator:

Resten Imaoka, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Kyersten Hoene

9209796340khoene@mcw.edu

Principal Investigator:

Matthew Scheidt, MD

More Information

Sponsor

Society of Interventional Oncology

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Society of Interventional Oncology on 2026-08-19.