Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-008415
NCT ID: NCT02225223
Sponsor Protocol Number: DF-14-01
About this 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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,
- Significant clinical morbidities (aside from the index vertebra(e) and recurrent cancer) that may interfere with data collection that affects pain and functional results,
- Medical/surgical conditions contrary to the kyphoplasty procedure (e.g., presence of active or incompletely treated local infection, severe pulmonary insufficiency),
- Bedridden due to paralysis or neurological decline,
- Currently pregnant or nursing, or planning pregnancy (in the period up to 6 months) following the index procedure(s),
- Known allergy to bone cement,
- Has a heart pacemaker or other electronic device implants
- 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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Jonathan Morris, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available