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

Sponsors and Collaborators:	M.D. Anderson Cancer Center ArthroCare Corporation
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00819832

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 IV

MedlinePlus related topics: Cancer Fractures Spinal Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
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

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

Primary Outcome Measures:

First phase is to learn if there is an increase in the number of cancer cells in a patient's blood after treatment (kyphoplasty or vertebroplasty) of broken back bone(s) that may have been caused by cancer. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
Second phase is to learn if using a device called the Cavity SpineWand right before treatment for broken back bone(s) that may have been caused by cancer can help to decrease the number of cancer cells in a patient's blood after surgery. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]
To compare the 4 surgical methods (kyphoplasty alone, vertebroplasty alone, kyphoplasty with the Cavity SpineWand, and vertebroplasty with the Cavity SpineWand) to learn if any of them can cause decreased back pain. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

In First Phase, if an increase in the number of cancer cells, learn exactly when after treatment the most cancer cells are found in the blood. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Phase 1 Group 1	Procedure: Vertebroplasty Medical cement will be injected into broken back bone.
2: Experimental Phase 1 Group 2	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.
3: Active Comparator Phase 2 Group 1: Vertebroplasty	Procedure: Vertebroplasty Medical cement will be injected into broken back bone.
4: Active Comparator Phase 2 Group 2: 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).
5: Active Comparator Phase 2 Group 3: 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.
6: Active Comparator Phase 2 Group 4: 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

Contacts

Contact: Dawid Schellingerhout, MD

713-792-3817

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Dawid Schellingerhout, MD

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:	UT MD Anderson Cancer Center ( Dawid Schellingerhout, MD/Asst. Professor )
Study ID Numbers:	2007-0593
Study First Received:	January 7, 2009
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00819832 History of Changes
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

Study placed in the following topic categories:

Spinal Diseases
Fractures, Compression
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries

Neoplasm Metastasis
Disorders of Environmental Origin
Pain
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Fractures, Compression
Musculoskeletal Diseases
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Bone Diseases

ClinicalTrials.gov processed this record on May 06, 2009