Status:
TERMINATED
Anderson Circulating Tumor Cell Burden (CTCB) Study
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
ArthroCare Corporation
Conditions:
Cancer
Spinal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 s...
Detailed Description
Kyphoplasty and Vertebroplasty: Kyphoplasty and vertebroplasty are types of surgery that are used to treat broken bones in the back, which may have been caused by cancer. Both procedures involve inje...
Eligibility Criteria
Inclusion
- 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.
- Patient agrees to participate in the clinical study and to complete all required visits and evaluations.
- Patient's vertebrae can safely be accessed with an 8 Gauge Cannula.
- Suitable test for Circulating Tumor Cell Burden (CTCB) is available.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00819832
Start Date
December 1 2008
End Date
May 1 2010
Last Update
March 24 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030