Metastatic Lesions in Vertebral BodiesSTARRTNCT02225223
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
A study testing STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System in people with Metastatic Lesions in Vertebral Bodies, run by Merit Medical Systems, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy. 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
- 35 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female patient is ≥ 18 years old,
- One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
- Never received radiation therapy at index level(s) (following consult with radiation oncologist re: conventional treatment options) OR Received radiation therapy without adequate relief from metastatic bone pain as determined by the patient and treating physician, their treating physician would not prescribe additional radiation treatments, or refuse additional radiation therapy,
- Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),
- Woman of potential childbearing age agrees to a medically effective birth control method,
- Life expectancy of ≥ 2 months,
- Sufficient mental capacity to comply with the protocol requirements,
- Understands the potential risks and benefits of study participation and is willing to provide written informed consent.
Who cannot join
- Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),
- Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),
- Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index vertebra (e),
- Compromise in the posterior column of the vertebral body or walls of pedicles.
- Extra-osseous extension of metastatic lesion is >10mm,
- Nonreversible or uncorrectable coagulopathy. INR should not be >1.5,
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- Platelet count of < 50,000 ,
- Radiation therapy was completed on the index vertebra(e) ≤ 28 days before enrollment,
- Change in chemotherapy agent is planned 7 days before or after enrollment (change in dose(s) permitted),
- Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,
- Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra(e),
- Spinal cord compression or canal compromise requiring decompression,
- Major surgery of the spine in same region as the index vertebra(e) was performed within 3 months before enrollment,
- Major elective surgery to the spine in same region as the index vertebra(e) is planned within 1 month following the ablation and cement procedure,
- Requires upper and lower limb surgery that will affect functional outcomes,
- Significant clinical morbidities (aside from the index vertebra(e) and recurrent cancer) that may interfere with data collection that affects pain and functional results,
- Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of active or incompletely treated local infection, severe pulmonary insufficiency),
- Bedridden due to paralysis or neurological decline,
- Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months) following the index procedure(s),
- Known allergy to bone cement,
- Has a heart pacemaker or other electronic device implants
- Concurrent participation or participation within the last 30 days prior to enrollment in any clinical trial with an investigational medicinal drug/chemotherapeutic or biologic or medical product.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Inova Alexandria Hospital
Alexandria, Virginia, 22304
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
University of Texas Southwestern
Dallas, Texas, 75390-9183
University of Kansas Medical Center
Kansas City, Kansas, 66160
Vascular and Interventional Radiology
La Grange, Illinois, 60439
USC
Los Angeles, California, 90032-9235
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Mayo Clinic
Rochester, Minnesota, 55901
St. Marks Hospital
Salt Lake City, Utah, 84107
Providence Sacred Heart
Spokane, Washington, 99204
Washington University/Siteman Cancer Center
St Louis, Missouri, 63110
Moffitt Cancer Center
Tampa, Florida, 33612
Torrance Memorial Medical Center
Torrance, California, 90505
Wake Forest
Winston-Salem, North Carolina, 27157
About this study
Official title: Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
Read the detailed description
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Being tested
- STAR™ Tumor Ablation System, StabiliT® Vertebral Augmentation System
- Keywords
- metastatic lesions, vertebral body, ablation, radiation, targeted radio-frequency ablation, radio-frequency targeted vertebral augmentation, radiofrequency kyphoplasty, spine, vertebral augmentation, kyphoplasty, spinal ablation, pain, quality of life, spinal tumors
- Medical subject headings
- Pain, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STAR™ Tumor Ablation SystemDevice
Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation SystemDevice
Radiofrequency-targeted vertebral augmentation (RF-TVA)
| Study group | Role | What they receive |
|---|---|---|
| No previous Radiation Therapy | Other | Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System. Receives: Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System |
| Failed/Refuse further Radiation Therapy | Other | Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System. Receives: Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
Measured: Mean change from baseline to 6 weeks
Secondary outcomes (2)
Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks
Measured by Brief Pain Inventory (BPI) Pain Q3, The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is measuring the mean change from baseline in BPI worst pain score prior to 6 weeks.
Measured: Mean Change from Baseline prior to 6 weeks
Brief Pain Inventory Q3 Worst Pain Score by Visit
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Secondary outcome is the response to Q3 at Weeks 1, 2 and 6.
Measured: Week 1, Week 2, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Difficulty Enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merit Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DFINE Inc.
- Responsible party
- Sponsor
- Investigators
- Jack Jennings, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225223
- Sponsor's protocol ID
- DF-14-01
- Acronym
- STARRT
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2014
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation Prior to or Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s) [The STARRT Study]
- ClinicalTrials.gov ID
- NCT02225223
- Acronym / sponsor ID
- STARRT / DF-14-01
- Conditions
- Metastatic Lesions in Vertebral Bodies
- Keywords
- metastatic lesions, vertebral body, ablation, radiation, targeted radio-frequency ablation, radio-frequency targeted vertebral augmentation, radiofrequency kyphoplasty, spine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty Enrolling
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Merit Medical Systems, Inc.Industry (pharma, biotech, devices)
- Collaborators
- DFINE Inc.
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Posted 21 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following radiation therapy.
Detailed description
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and "No Previous RT"
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No previous Radiation Therapy | Other | Device: STAR™ Tumor Ablation System, Device: StabiliT® Vertebral Augmentation SystemTargeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System. |
| Failed/Refuse further Radiation Therapy | Other | Device: STAR™ Tumor Ablation System, Device: StabiliT® Vertebral Augmentation SystemTargeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the 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 (8 listed)
- Male or female patient is ≥ 18 years old,
- One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
- Never received radiation therapy at index level(s) (following consult with radiation oncologist re: conventional treatment options) OR Received radiation therapy without adequate relief from metastatic bone pain as determined by the patient and treating physician, their treating physician would not prescribe additional radiation treatments, or refuse additional radiation therapy,
- Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),
- Woman of potential childbearing age agrees to a medically effective birth control method,
Key exclusion criteria (22 listed)
- Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e),
- Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),
- Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index vertebra (e),
- Compromise in the posterior column of the vertebral body or walls of pedicles.
- Extra-osseous extension of metastatic lesion is >10mm,
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 SystemTargeted-radiofrequency ablation (t-RFA) | Device | Failed/Refuse further Radiation Therapy, No previous Radiation Therapy |
| StabiliT® Vertebral Augmentation SystemRadiofrequency-targeted vertebral augmentation (RF-TVA) | Device | Failed/Refuse further Radiation Therapy, No previous Radiation Therapy |
Primary outcome
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks
Time frame: Mean change from baseline to 6 weeks
The Brief Pain Inventory (BPI) short form rates pain on a scale from 0 to 10 (with 0=no pain and 10=worst pain you can imagine). The response is from Q3 reporting worst pain within the last 24 hours. Primary outcome is measuring the mean change from baseline in BPI worst pain score at 6 weeks.
2 secondary outcomes
Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks
Time frame: Mean Change from Baseline prior to 6 weeks
Brief Pain Inventory Q3 Worst Pain Score by Visit
Time frame: Week 1, Week 2, Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Jack Jennings, MD principal investigator
Washington University School of Medicine
14 sites in 1 country: 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 Merit Medical Systems, Inc. at 14 sites in United States.
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 8 inclusion and 22 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 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks (time frame: Mean change from baseline to 6 weeks). 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 11 Aug 2021.