A Multi-Center Observational Trial of Symptomatic, High-Risk Bone Metastases Treated With Percutaneous Ablation and Palliative Radiation Therapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21+
SponsorSociety of Interventional Oncology

About this trial

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).

Eligibility criteria

Qualifiers

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)

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Percutaneous Ablation
  • Radiation Therapy

Treatment groups

No treatment groups listed