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

Not Applicable

Terminated

• Conditions: Metastatic Lesions in Vertebral Bodies
• Interventions: Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System

• Registration Number: NCT02225223
• Lead Sponsor: Merit Medical Systems, Inc.

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"

Study Timeline

• Study First Submitted: 2014-08-21
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Study Start: 2014-12
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2021-05-17
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-01
• Last Update Submitted: 2021-07-20
• Results First Posted: 2021-07-21
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Failed/Refuse further Radiation Therapy	StabiliT® Vertebral Augmentation System	Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
Failed/Refuse further Radiation Therapy	STAR™ Tumor Ablation System	Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
No previous Radiation Therapy	STAR™ Tumor Ablation System	Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.
No previous Radiation Therapy	StabiliT® Vertebral Augmentation System	Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (14)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

USC; 🇺🇸 Los Angeles, California, United States

Torrance Memorial Medical Center; 🇺🇸 Torrance, California, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Vascular and Interventional Radiology; 🇺🇸 La Grange, Illinois, United States

St. Marks Hospital; 🇺🇸 Salt Lake City, Utah, United States

Northwestern University, Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Providence Sacred Heart; 🇺🇸 Spokane, Washington, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Inova Alexandria Hospital; 🇺🇸 Alexandria, Virginia, United States

Washington University/Siteman Cancer Center; 🇺🇸 Saint Louis, Missouri, United States

Wake Forest; 🇺🇸 Winston-Salem, North Carolina, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States