Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors

Not Applicable

Terminated

• Conditions: Metastatic Lesions in Vertebral Bodies

• Registration Number: NCT02081053
• Lead Sponsor: DFINE Inc.

Brief Summary

To evaluate the clinical outcomes of minimally invasive targeted radiofrequency tumor ablation (t-RFA) and kyphoplasty (also known as vertebral augmentation) in painful metastatic lesions in the spine.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• One to 2 painful vertebrae (T1-L5) with evidence of osteolytic metastatic lesion with known primary histology with pathologic fracture(s) at index vertebra by MRI
• Pain score ≥ 4 on the numerical rating pain scale
• Life expectancy of ≥ 6 months

Exclusion Criteria

• Primary tumors of the bone at index vertebra
• Benign tumors of the bone at index vertebra
• Osteoblastic tumors at index vertebra
• Index vertebra with more than one (1) pedicle involved
• Epidural extension of tumor within 5 mm of the spinal cord or without sufficient room for thermal protective maneuvers
• Spinal cord compression or canal compromise requiring decompression
• Radiation therapy is planned to be started on the index vertebra within 4 weeks post procedure
• Radiation therapy was performed on the index vertebra within 2 months before enrollment
• Major surgery of the spine was performed within 3 months before enrollment
• Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty
• Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pain relief	1 month	Measured by the Numerical Rating Pain Scale (NRPS)

Secondary Outcome Measures

Name	Time	Method
Change in pain medications	up to 6 months
Change in function	up to 6 months	Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)
Change in Quality of Life	up to 6 months	Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)

Trial Locations

Locations (8)

Nouvel Höpital Civil; 🇫🇷 Strasbourg, France

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Goethe-Universität Frankfurt am Main; 🇩🇪 Frankfurt, Germany

Universität zu Köln; 🇩🇪 Köln, Germany

Otto-von-Guericke-Universität Magdeburg; 🇩🇪 Magdeburg, Germany

Cardarelli Hospital Naples, Italy; 🇮🇹 Naples, Italy

Policlinico Tor Vergata; 🇮🇹 Rome, Italy

Ospedale di Treviso Ca' Foncello; 🇮🇹 Treviso, Italy