Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
NCT ID: NCT02225223
Last Updated: 2021-08-11
Study Results
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View full resultsBasic Information
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TERMINATED
NA
35 participants
INTERVENTIONAL
2014-12-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No previous Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System
Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System
Radiofrequency-targeted vertebral augmentation (RF-TVA)
Failed/Refuse further Radiation Therapy
Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
STAR™ Tumor Ablation System
Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System
Radiofrequency-targeted vertebral augmentation (RF-TVA)
Interventions
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STAR™ Tumor Ablation System
Targeted-radiofrequency ablation (t-RFA)
StabiliT® Vertebral Augmentation System
Radiofrequency-targeted vertebral augmentation (RF-TVA)
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. 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,
4. Brief Pain Inventory (BPI) worst pain score of ≥ 4 (irrespective of medication),
5. Woman of potential childbearing age agrees to a medically effective birth control method,
6. Life expectancy of ≥ 2 months,
7. Sufficient mental capacity to comply with the protocol requirements,
8. Understands the potential risks and benefits of study participation and is willing to provide written informed consent.
Exclusion Criteria
2. Benign tumors of the bone (e.g. osteoid osteoma) at site of index vertebra (e),
3. Lesions due to hematologic malignancy (e.g. multiple myeloma at site of the index vertebra (e),
4. Compromise in the posterior column of the vertebral body or walls of pedicles.
5. Extra-osseous extension of metastatic lesion is \>10mm,
6. Nonreversible or uncorrectable coagulopathy. INR should not be \>1.5,
7. Platelet count of \< 50,000 ,
8. Radiation therapy was completed on the index vertebra(e) ≤ 28 days before enrollment,
9. Change in chemotherapy agent is planned 7 days before or after enrollment (change in dose(s) permitted),
10. Index vertebra(e) had previous spine surgery including vertebroplasty or kyphoplasty,
11. Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra(e),
12. Spinal cord compression or canal compromise requiring decompression,
13. Major surgery of the spine in same region as the index vertebra(e) was performed within 3 months before enrollment,
14. 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,
15. Requires upper and lower limb surgery that will affect functional outcomes,
16. Significant clinical morbidities (aside from the index vertebra(e) and recurrent cancer) that may interfere with data collection that affects pain and functional results,
17. Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of active or incompletely treated local infection, severe pulmonary insufficiency),
18. Bedridden due to paralysis or neurological decline,
19. Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months) following the index procedure(s),
20. Known allergy to bone cement,
21. Has a heart pacemaker or other electronic device implants
22. 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.
18 Years
ALL
No
Sponsors
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DFINE Inc.
INDUSTRY
Merit Medical Systems, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jack Jennings, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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USC
Los Angeles, California, United States
Torrance Memorial Medical Center
Torrance, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Vascular and Interventional Radiology
La Grange, Illinois, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University/Siteman Cancer Center
St Louis, Missouri, United States
Wake Forest
Winston-Salem, North Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
St. Marks Hospital
Salt Lake City, Utah, United States
Inova Alexandria Hospital
Alexandria, Virginia, United States
Providence Sacred Heart
Spokane, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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DF-14-01
Identifier Type: -
Identifier Source: org_study_id
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