Metastatic Lesions in Vertebral BodiesEU-STARNCT02081053
Evaluating Clinical Outcomes of Targeted Radiofrequency Ablation and Kyphoplasty (Also Known as Vertebral Augmentation) to Treat Painful Metastatic Vertebral Body Tumors
A study testing STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System in people with Metastatic Lesions in Vertebral Bodies, run by DFINE Inc. at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lesions in Vertebral Bodies
- What is being tested?
- STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jan 2014to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany4 sites
Universitätsklinikum Bonn
Bonn, 53127
Universität zu Köln
Cologne, 50931
Goethe-Universität Frankfurt am Main
Frankfurt, 60590
Otto-von-Guericke-Universität Magdeburg
Magdeburg, 39120
Italy3 sites
Cardarelli Hospital Naples, Italy
Naples
Policlinico Tor Vergata
Rome
Ospedale di Treviso Ca' Foncello
Treviso
About this study
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)
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.
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Being tested
- STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System
- 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
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation SystemDevice
Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)
| Study group | Role | What they receive |
|---|---|---|
| RF Ablation and Vertebral Augmentation | Other | Not described Receives: Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured by the Numerical Rating Pain Scale (NRPS)
Measured: 1 month
Secondary outcomes (3)
Change in function
Measured by Modified Oswestry Low Back Pain Disability Questionnaire (m-ODI)
Measured: up to 6 months
Change in Quality of Life
Measured by European Organization for Research and Treatment of Cancer and Bone Metastasis Questionnaires (EORTC-C30 and EORTC-BM22)
Measured: up to 6 months
Change in pain medications
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Difficulty Enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Lesions in Vertebral BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- DFINE Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Vogl, MD, Principal investigator, Goethe-Universität Frankfurt am Main
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081053
- Sponsor's protocol ID
- DF-13-03
- Acronym
- EU-STAR
- Status last verified
- Jan 2017
- First submitted
- 4 Mar 2014
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02081053
- Acronym / sponsor ID
- EU-STAR / DF-13-03
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty Enrolling
- Enrolment
- 30 participants (actual)
- Lead sponsor
- DFINE Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RF Ablation and Vertebral Augmentation | Other | Device: STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation SystemRadiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA) | Device | RF Ablation and Vertebral Augmentation |
Primary outcome
Pain relief
Time frame: 1 month
Measured by the Numerical Rating Pain Scale (NRPS)
3 secondary outcomes
Change in function
Time frame: up to 6 months
Change in Quality of Life
Time frame: up to 6 months
Change in pain medications
Time frame: up to 6 months
Results and safety
The study was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Vogl, MD principal investigator
Goethe-Universität Frankfurt am Main
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System in people with Metastatic Lesions in Vertebral Bodies, run by DFINE Inc. at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulty Enrolling). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.