Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

Study Overview
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Brief Summary
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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
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Prospective, multi-center clinical study. Stratification scheme: 'Failed/Refused Further RT' and No Previous RT

Official Title
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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]

Conditions
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Metastatic Lesions in Vertebral Bodies

Intervention / Treatment
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* Device: STAR™ Tumor Ablation System
* Device: StabiliT® Vertebral Augmentation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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, 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No previous Radiation Therapy<br>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System. | Device: STAR™ Tumor Ablation System<br>* Targeted-radiofrequency ablation (t-RFA)<br>Device: StabiliT® Vertebral Augmentation System<br>* Radiofrequency-targeted vertebral augmentation (RF-TVA)<br>|
| Other: Failed/Refuse further Radiation Therapy<br>Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System. | Device: STAR™ Tumor Ablation System<br>* Targeted-radiofrequency ablation (t-RFA)<br>Device: StabiliT® Vertebral Augmentation System<br>* Radiofrequency-targeted vertebral augmentation (RF-TVA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Mean change from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Week 1, Week 2, Week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spine, metastatic lesions, vertebral body, ablation, radiation, targeted radio-frequency ablation, radio-frequency targeted vertebral augmentation, radiofrequency kyphoplasty, vertebral augmentation, kyphoplasty, spinal ablation, pain, quality of life, spinal tumors