Metastatic Lesions in Vertebral Bodies
Conditions
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
Brief 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.
Detailed description
Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and No Previous RT
Interventions
Targeted-radiofrequency ablation (t-RFA)
DEVICEStabiliT® Vertebral Augmentation System
Radiofrequency-targeted vertebral augmentation (RF-TVA)
Sponsors
DFINE Inc.
Merit Medical Systems, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patient is ≥ 18 years old, 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
1. Primary tumors of the bone (e.g., osteosarcoma) at site of index vertebra(e), 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks | Mean Change from Baseline 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. |
| Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 1, Week 2, Week 6 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 27 |
| 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) | 8 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 10 | 1 |
| Overall Study | Lost to Follow-up | 5 | 0 |
| Overall Study | Other | 1 | 2 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | No Previous Radiation Therapy | Total | Failed/Refuse Further Radiation Therapy |
|---|---|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 15.3 | 60.2 years STANDARD_DEVIATION 15.52 | 53.4 years STANDARD_DEVIATION 15.23 |
| Brief Pain Inventory (BPI -Short Form) - 24 hour worst pain | 7.9 units on a scale STANDARD_DEVIATION 1.93 | 7.7 units on a scale STANDARD_DEVIATION 1.84 | 7.1 units on a scale STANDARD_DEVIATION 1.46 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 34 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Primary Cancer Breast Cancer | 6 Participants | 8 Participants | 2 Participants |
| Primary Cancer Non-Small Cell Lung Cancer | 2 Participants | 3 Participants | 1 Participants |
| Primary Cancer Other | 13 Participants | 16 Participants | 3 Participants |
| Primary Cancer Prostate Cancer | 1 Participants | 3 Participants | 2 Participants |
| Primary Cancer Prostate Cancer and Other | 2 Participants | 2 Participants | 0 Participants |
| Primary Cancer Small Cell Lung Cancer | 2 Participants | 2 Participants | 0 Participants |
| Primary Cancer Thyroid Cancer | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 27 Participants | 4 Participants |
| Sex: Female, Male Female | 15 Participants | 19 Participants | 4 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 27 | 1 / 8 |
| other Total, other adverse events | 0 / 27 | 0 / 8 |
| serious Total, serious adverse events | 0 / 27 | 0 / 8 |
Outcome results
Primary
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.
Time frame: Mean change from baseline to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Previous Radiation Therapy | Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks | 2.3 score on a scale | Standard Deviation 1.48 |
| Failed/Refuse Further Radiation Therapy | Mean Change From Baseline in Brief Pain Inventory Q3 Worst Pain Score at 6 Weeks | 1.8 score on a scale | Standard Deviation 1.13 |
Secondary
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.
Time frame: Week 1, Week 2, Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Previous Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 1 | 4.5 score on a scale | Standard Deviation 3 |
| No Previous Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 2 | 3.9 score on a scale | Standard Deviation 3.05 |
| No Previous Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 6 | 3.6 score on a scale | Standard Deviation 2.87 |
| Failed/Refuse Further Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 6 | 3.8 score on a scale | Standard Deviation 1.91 |
| Failed/Refuse Further Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 1 | 4.9 score on a scale | Standard Deviation 2.67 |
| Failed/Refuse Further Radiation Therapy | Brief Pain Inventory Q3 Worst Pain Score by Visit | Week 2 | 5.3 score on a scale | Standard Deviation 2.12 |
Secondary
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.
Time frame: Mean Change from Baseline prior to 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Previous Radiation Therapy | Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks | 2.1 score on a scale | Standard Deviation 1.75 |
| Failed/Refuse Further Radiation Therapy | Mean Change From Baseline in Brief Pain Inventory Worst Pain Score at Visits Prior to 6 Weeks | 1.5 score on a scale | Standard Deviation 1.24 |