Anderson Circulating Tumor Cell Burden (CTCB) Study
Condition: Cancer; Spinal Disease; Vertebral Compression Fractures
MeSH terms: Neoplastic Cells, Circulating; Spinal Diseases; Fractures, Bone; Fractures, Compression
Intervention: Kyphoplasty; Vertebroplasty; Cavity SpineWand
Intervention description: A small fluid balloon will create a hole in the broken back bone where tumor is located. After balloon deflation and removal, hole is filled with medical cement.; Medical cement will be injected into broken back bone.; Removes tissue (soft tissue, bone tissue, or both, but this will vary from person to person), including all or part of the cancerous tumors in the area of the broken back bone(s).
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: vertebral compression fractures; VCF; Spinal; Broken spinal bones; Kyphoplasty; vertebroplasty; Cavity SpineWand; Circulating Tumor Cell Burden; CTCB; Spine pain; Coblation; plasma radiofrequency ablation; Plasma-mediated ablation technology; precise molecular dissociation (ablation) process; medical cement

Summary:

      Phase 1 - Optimization Phase:

      Primary Objective: The primary objective of Phase 1 of this study is to determine the time
      point at which maximal Circulating Tumor Cell Burden (CTCB) occurs following standard
      vertebroplasty and Kyphoplasty procedures relative to baseline CTCB.

      Phase 2 - Comparison Phase:

      Primary Objective: The primary objective of Phase 2 of this study is to determine the change
      in CTCB from baseline to post-treatment as measured using the CellSearch™ Assay and to
      compare the average change between treatment groups with and without the use of the Cavity
      SpineWand.

      Secondary Objectives:

        -  To determine the change in self-reported pain level from baseline to post-treatment as
           measured using the visual analogue scale (VAS) for spine pain and to compare the average
           change in pain level between treatment groups.

        -  To determine the change in pain status from baseline to post-treatment as measured using
           the Brief Pain Inventory (BPI) and to compare the average change in pain status between
           treatment groups.

        -  To determine the change from baseline to post-treatment in the M.D. Anderson Cancer
           Center Symptom Inventory (MDASI) and to compare the average change between treatment
           groups.

        -  To determine the change from baseline to post-treatment in time to walk a 50-foot
           distance and to compare the average change between treatment groups.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patient is >18 years old.

          2. Patient is a candidate for standard vertebroplasty or Kyphoplasty with reasonable
             safety, as determined by the physician performing the procedure.

          3. Patient is medically fit to undergo conscious sedation.

          4. Patient is able to understand and give consent to participation in the study.

          5. Patient presents with back pain >= 50 (on a 0-100 VAS scale).

          6. Patient presents with a vertebral compression fracture believed to be due to
             malignancy.

          7. Patient agrees to undergo, prior to the procedure, both magnetic resonance imaging
             (MRI, within 45 days of the planned procedure) and computed tomography (CT, within 14
             days of the procedure). If MRI is contraindicated (due to pacemakers, intracranial
             ferromagnetic metal, etc), imaging with a nuclear medicine bone scan could be used as
             an alternative. CT remains mandated as a planning modality for all cases.

          8. Patient has a life expectancy of at least 4 months.

          9. Patient agrees to participate in the clinical study and to complete all required
             visits and evaluations.

         10. Patient's vertebrae can safely be accessed with an 8 Gauge Cannula.

         11. Suitable test for Circulating Tumor Cell Burden (CTCB) is available.

        Exclusion Criteria:

          1. Patient has unfavorable surgical anatomy to indicate that the patient could not be
             safely treated in any one of the four surgical groups if the patient was randomized to
             that group.

          2. Patient has uncorrectable coagulopathy.

          3. The metastatic lesions are determined to be blastic in nature and contain such
             sclerotic bone that the fracture site cannot adequately be accessed.

          4. Vertebral compression fractures are present at multiple-levels and more than 2 levels
             must be treated during the same surgery (patients who have multi-level disease can
             still be enrolled provided no more than 2 levels be treated at one occasion).

          5. Patient has significant risk of procedure-related complications due to potential
             interactions with devices or materials used in the procedures, i.e., Pacemaker implant
             or Allergy (e.g., to cement, cannula metal, contrast medium, etc.)

          6. Patient is unable to provide informed consent.