Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around
Principal Investigator
by Anthony Tadros, MD (ucsd)Kathryn Tringale, MD (ucsd)

Description

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).

Keywords

Bone Cancer Metastatic, Catheter Ablation, Radiotherapy, Percutaneous Ablation, Radiation Therapy

Eligibility

You can join if…

Open to people ages 21 years and up

    1. Skeletal metastasis with localized pain not controlled medically [recall within last 24 hours of worst pain ≥ 5 using the BPI]
    1. 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)
    1. Lesions that are at high-risk of skeletal related events defined as follows:
    1. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesions involving the spine
    1. Pelvic and appendicular lytic lesions with or without cortical breakthrough causing functional/mechanical pain
    1. Target lesion amenable to percutaneous ablation with image guidance AND RT by specialists' review
    1. No prior targeted radiation therapy or ablation to the index lesion
    1. ECOG performance status 0-2
    1. Age ≥ 21 years
    1. Have signed the current approved informed consent form
    1. 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
    1. Life expectancy > 3 months

You CAN'T join if...

    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.
    1. Target tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone [MIREL Score ≥ 7]
    1. Skeletal lesions with unstable pathologic fractures requiring immediate surgical stabilization
    1. Concurrent participation in other studies that could affect the primary endpoint
    1. Target tumor causing clinical or imaging evidence of spinal cord compression

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Mayo Clinic accepting new patients
    Rochester Minnesota 55905 United States

Lead Scientists at University of California Health

  • Anthony Tadros, MD (ucsd)
    Associate Clinical Professor, Radiology, Vc-health Sciences-schools. Authored (or co-authored) 18 research publications
  • Kathryn Tringale, MD (ucsd)
    Assistant Professor In Residence, Radiation Medicine and Applied Science, Vc-health Sciences-schools. Authored (or co-authored) 85 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Society of Interventional Oncology
ID
NCT06859801
Study Type
Observational
Participants
Expecting 120 study participants
Last Updated