Clinical trial NCT02081053: Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors
Official title: A Prospective, Multicenter Clinical Study to Evaluate the Clinical Outcomes of Targeted Radiofrequency Ablation and Vertebral Augmentation to Treat Painful Metastatic Vertebral Body Tumor(s)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Lesions in Vertebral Bodies
Keywords: metastatic lesions
vertebral body
ablation
targeted radio-frequency ablation
radio-frequency targeted vertebral augmentation
radiofrequency kyphoplasty
spine
vertebral augmentation
kyphoplasty
spinal ablation
pain
quality of life
Lead sponsor: Merit Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain relief
timeFrame: 1 month
Secondary outcomes:
measure: Change in function
timeFrame: up to 6 months
measure: Change in Quality of Life
timeFrame: up to 6 months
measure: Change in pain medications
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Nouvel Höpital Civil
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Frankfurt
country: Germany
facility: Goethe-Universität Frankfurt am Main
city: Köln
country: Germany
facility: Universität zu Köln
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg
city: Naples
country: Italy
facility: Cardarelli Hospital Naples, Italy
city: Rome
country: Italy
facility: Policlinico Tor Vergata
city: Treviso
country: Italy
facility: Ospedale di Treviso Ca' Foncello
Study officials:
affiliation: Goethe-Universität Frankfurt am Main
name: Thomas Vogl, MD
role: PRINCIPAL_INVESTIGATOR
References: