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

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.

Study Overview

• Status: Terminated
• Conditions: Metastatic Lesions in Vertebral Bodies
• Intervention / Treatment: Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90032-9235
      • USC
    • Torrance, California, United States, 90505
      • Torrance Memorial Medical Center
  • Florida
    • Tampa, Florida, United States, 33612
      • Moffitt Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University, Feinberg School of Medicine
    • La Grange, Illinois, United States, 60439
      • Vascular and Interventional Radiology
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Minnesota
    • Rochester, Minnesota, United States, 55901
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University/Siteman Cancer Center
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest
  • Texas
    • Dallas, Texas, United States, 75390-9183
      • University of Texas Southwestern
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • St. Marks Hospital
  • Virginia
    • Alexandria, Virginia, United States, 22304
      • Inova Alexandria Hospital
  • Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merit Medical Systems, Inc.
• Collaborators: DFINE Inc.
• Investigators: Principal Investigator: Jack Jennings, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: pain; quality of life; radiation; ablation; spine; kyphoplasty; metastatic lesions; vertebral body; targeted radio-frequency ablation; radio-frequency targeted vertebral augmentation; radiofrequency kyphoplasty; vertebral augmentation; spinal ablation; spinal tumors
• Other Study ID Numbers: DF-14-01