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

Merit Medical Systems

Status: Terminated

Conditions: Metastatic Lesions in Vertebral Bodies

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02225223

DF-14-01

Details and patient eligibility

About

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.

Full description

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 2 patient groups

No previous Radiation Therapy

Other group

Description:

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

Treatment:

Device: STAR™ Tumor Ablation System

Device: StabiliT® Vertebral Augmentation System

Failed/Refuse further Radiation Therapy

Other group

Description:

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

Treatment:

Device: STAR™ Tumor Ablation System

Device: StabiliT® Vertebral Augmentation System