Phase
Condition
N/ATreatment
Radiation Therapy
Percutaneous Ablation
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Skeletal metastasis with localized pain not controlled medically [recall withinlast 24 hours of worst pain ≥ 5 using the BPI]
- Pain must be from one painful metastatic lesion involving the bone (additionalless painful metastatic sites may be present). Extra-osseous extension of disease isallowed (must have some contact with the bone and be causing bone/tumor interfacepain)
- Lesions that are at high-risk of skeletal related events defined as follows:
a. Minimum Spinal Instability Neoplastic Score (SINS) score ≥ 7 for lesionsinvolving the spine
b. Pelvic and appendicular lytic lesions with or without cortical breakthroughcausing functional/mechanical pain
- Target lesion amenable to percutaneous ablation with image guidance AND RT byspecialists' review
- No prior targeted radiation therapy or ablation to the index lesion
- ECOG performance status 0-2
- Age ≥ 21 years
- Have signed the current approved informed consent form
- 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
- Life expectancy > 3 months
Exclusion
Exclusion Criteria:
- 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 precludethe patient's successful completion of the clinical trial.
- Target tumor involves a weight-bearing long bone of the lower extremity with thetumor causing > 50% loss of cortical bone [MIREL Score ≥ 7]
- Skeletal lesions with unstable pathologic fractures requiring immediate surgicalstabilization
- Concurrent participation in other studies that could affect the primary endpoint
- Target tumor causing clinical or imaging evidence of spinal cord compression
Study Design
Connect with a study center
University of California San Diego Moores Cancer Center
San Diego 5391811, California 5332921 92093
United StatesActive - Recruiting
Emory University Hospital
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
Northside Hospital
Atlanta 4180439, Georgia 4197000 30342
United StatesActive - Recruiting
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.