Anderson Circulating Tumor Cell Burden (CTCB) Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Cancer Spinal Disease Vertebral Compression Fractures	Procedure: Kyphoplasty Procedure: Vertebroplasty Device: Cavity SpineWand	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Assessment of Circulating Tumor Cell Burden After Radiofrequency-Based Plasma Ablation (COBLATION®) in Conjunction With Vertebroplasty or Kyphoplasty for Augmenting Painful Vertebral Compression Fractures Secondary to Malignancy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fractures Spine Injuries and Disorders

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB) [ Time Frame: Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days) ] [ Designated as safety issue: Yes ]
Increase in number of cancer cells in patient's blood after standard kyphoplasty or vertebroplasty treatment of broken back bones that may have been caused by cancer measured by CTCB evaluation from peripheral blood (10cc) collected at 8 varying time points for a total of 100 cc collected over the 7 day period of time (10, 30, and 60 minutes, and then at 2 hours, and between 6-8 hours, 10-18 hours, 20-28 hours, and 7 days after the surgery).
Phase 2: Change in CTCB From Baseline to Post-treatment [ Time Frame: CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days) ] [ Designated as safety issue: No ]

Enrollment:	3
Study Start Date:	December 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Phase 1 Group 1 Vertebroplasty Vertebroplasty	Procedure: Vertebroplasty Medical cement will be injected into broken back bone.
Experimental: Phase 1 Group 2 Kyphoplasty Kyphoplasty	Procedure: Kyphoplasty 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.
Active Comparator: Phase 2 Group 1 Vertebroplasty Vertebroplasty	Procedure: Vertebroplasty Medical cement will be injected into broken back bone.
Active Comparator: Phase 2 Group 2 Vertebroplasty + Cavity SpineWand Vertebroplasty with Cavity SpineWand	Procedure: Vertebroplasty Medical cement will be injected into broken back bone. Device: Cavity SpineWand 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).
Active Comparator: Phase 2 Group 3 Kyphoplasty Kyphoplasty	Procedure: Kyphoplasty 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.
Active Comparator: Phase 2 Group 4 Kyphoplasty + Cavity SpineWand Kyphoplasty with Cavity SpineWand	Procedure: Kyphoplasty 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. Device: Cavity SpineWand 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).

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00819832

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

ArthroCare Corporation

Investigators

Principal Investigator:

Dawid Schellingerhout, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00819832 History of Changes
Obsolete Identifiers:	NCT00756054
Other Study ID Numbers:	2007-0593
Study First Received:	January 7, 2009
Results First Received:	August 16, 2010
Last Updated:	July 27, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

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

Additional relevant MeSH terms:

Fractures, Bone
Neoplastic Cells, Circulating
Spinal Diseases
Fractures, Compression
Wounds and Injuries
Neoplasm Metastasis

Neoplastic Processes
Neoplasms
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013