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

January 18, 2017 updated by: DFINE Inc.

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil
  • Germany
      • Bonn, Germany, 53127
        • Universitatsklinikum Bonn
      • Frankfurt, Germany, 60590
        • Goethe-Universität Frankfurt am Main
      • Köln, Germany, 50931
        • Universität zu Köln
      • Magdeburg, Germany, 39120
        • Otto-von-Guericke-Universität Magdeburg
  • Italy
      • Naples, Italy
        • Cardarelli Hospital Naples, Italy
      • Rome, Italy
        • Policlinico Tor Vergata
      • Treviso, Italy
        • Ospedale di Treviso Ca' Foncello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain relief
Time Frame: 1 month
Measured by the Numerical Rating Pain Scale (NRPS)
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DFINE Inc.

Investigators

  • Principal Investigator: Thomas Vogl, MD, Goethe-Universität Frankfurt am Main

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 18, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DF-13-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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