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

Sponsor

DFINE Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02081053

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Lesions in Vertebral Bodies	Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: RF Ablation and Vertebral Augmentation	Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)

Arm

Intervention/Treatment

Other: RF Ablation and Vertebral Augmentation

Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System

Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)

Outcome Measures

Primary Outcome Measures

Pain relief [1 month]
Measured by the Numerical Rating Pain Scale (NRPS)

Secondary Outcome Measures

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)
Change in pain medications [up to 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Nouvel Höpital Civil	Strasbourg	France	67091
2	Universitätsklinikum Bonn	Bonn	Germany	53127
3	Goethe-Universität Frankfurt am Main	Frankfurt	Germany	60590
4	Universität zu Köln	Köln	Germany	50931
5	Otto-von-Guericke-Universität Magdeburg	Magdeburg	Germany	39120
6	Cardarelli Hospital Naples, Italy	Naples	Italy
7	Policlinico Tor Vergata	Rome	Italy
8	Ospedale di Treviso Ca' Foncello	Treviso	Italy