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

Metastatic Lesions in Vertebral Bodies Clinical Trial

— STARRT  

Official title:

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]

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02225223
• Other study ID #: DF-14-01
• Status: Terminated
• Phase: N/A
• Start date: December 2014
• Est. completion date: October 2016

Study information

• Verified date: July 2021
• Source: Merit Medical Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Lesions in Vertebral Bodies

Intervention

Device:
• STAR™ Tumor Ablation System
Targeted-radiofrequency ablation (t-RFA)
• StabiliT® Vertebral Augmentation System
Radiofrequency-targeted vertebral augmentation (RF-TVA)

Locations

Country	Name	City	State
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	University of Texas Southwestern	Dallas	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Vascular and Interventional Radiology	La Grange	Illinois
United States	USC	Los Angeles	California
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University/Siteman Cancer Center	Saint Louis	Missouri
United States	St. Marks Hospital	Salt Lake City	Utah
United States	Providence Sacred Heart	Spokane	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Torrance Memorial Medical Center	Torrance	California
United States	Wake Forest	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Merit Medical Systems, Inc.	DFINE Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Mean change from baseline to 6 weeks
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.	Mean Change from Baseline prior to 6 weeks
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.	Week 1, Week 2, Week 6