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

NCT02225223 | Terminated Results

• 1 other identifier: DF-14-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 14

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.

Conditions

Metastatic Lesions in Vertebral Bodies

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• Brief Pain Inventory Q3 Worst Pain Score by Visit

  Week 1, Week 2, Week 6

Study Arms (2)

No previous Radiation Therapy

OTHER

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System

Failed/Refuse further Radiation Therapy

OTHER

Targeted radio-frequency ablation using the STAR™ Tumor Ablation System and vertebral augmentation using the StabiliT® Vertebral Augmentation System.

Device: STAR™ Tumor Ablation System; Device: StabiliT® Vertebral Augmentation System

Interventions

STAR™ Tumor Ablation System DEVICE

Targeted-radiofrequency ablation (t-RFA)

Failed/Refuse further Radiation Therapy; No previous Radiation Therapy

StabiliT® Vertebral Augmentation System DEVICE

Radiofrequency-targeted vertebral augmentation (RF-TVA)

Failed/Refuse further Radiation Therapy; No previous Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Merit Medical Systems, Inc.: lead
• DFINE Inc.: collaborator

Study Sites (14)

USC

Los Angeles, California, 90032-9235, United States

Location

Torrance Memorial Medical Center

Torrance, California, 90505, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Vascular and Interventional Radiology

La Grange, Illinois, 60439, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Washington University/Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Wake Forest

Winston-Salem, North Carolina, 27157, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390-9183, United States

Location

St. Marks Hospital

Salt Lake City, Utah, 84107, United States

Location

Inova Alexandria Hospital

Alexandria, Virginia, 22304, United States

Location

Providence Sacred Heart

Spokane, Washington, 99204, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Pain; Spinal Cord Neoplasms

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Study was terminated due to difficulty with enrollment. Analysis of data is limited due to early termination of study and incomplete enrollment and completion of study subjects.

Results Point of Contact

• Title: Casey Holland
• Organization: Merit Medical

casey.holland@merit.com

1 (617) 842-0251

Study Officials

• Jack Jennings, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: August 26, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 11, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-07

Locations

US (14)