Anderson Circulating Tumor Cell Burden (CTCB) Study (NCT00819832) | Clinical Trial Compass
TerminatedPhase 4
Anderson Circulating Tumor Cell Burden (CTCB) Study
Stopped: Terminated by sponsor.
United States3 participantsStarted 2008-12
Plain-language 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 CellSearchâ„¢ 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient is \>18 years old.
✓. Patient is a candidate for standard vertebroplasty or Kyphoplasty with reasonable safety, as determined by the physician performing the procedure.
✓. Patient is medically fit to undergo conscious sedation.
✓. Patient is able to understand and give consent to participation in the study.
✓. Patient presents with back pain \>= 50 (on a 0-100 VAS scale).
✓. Patient presents with a vertebral compression fracture believed to be due to malignancy.
✓. 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.
✓. Patient has a life expectancy of at least 4 months.
Exclusion criteria
What they're measuring
1
Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)
Timeframe: Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)
2
Phase 2: Change in CTCB From Baseline to Post-treatment
Timeframe: CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)
✕. 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.
✕. Patient has uncorrectable coagulopathy.
✕. The metastatic lesions are determined to be blastic in nature and contain such sclerotic bone that the fracture site cannot adequately be accessed.
✕. 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).
✕. 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.)
✕. Patient is unable to provide informed consent.