A Multi-Center Observational Trial Of Symptomatic High-Risk Bone Metastases Treated With Percutaneous Ablation And Palliative Radiation Therapy

Overview

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Brian Welch

Open for enrollment

Contact information:

Desirae Howe-Clayton

(507) 255-0111

Howe.Desirae@mayo.edu

More information

Publications

Publications are currently not available