Anderson Circulating Tumor Cell Burden (CTCB) Study

NCT00819832 | Terminated Phase 4 Results DMC

• 1 other identifier: 2007-0593
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cancer; Spinal Disease; Vertebral Compression Fractures

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

Outcome Measures

Primary Outcomes (2)

• Phase 1: Time to Maximal Circulating Tumor Cell Burden (CTCB)

  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).

  Pre-procedure baseline blood draws through post surgery 24 hours followed at 7 days (+/- 2 days)

• Phase 2: Change in CTCB From Baseline to Post-treatment

  CTCB evaluation performed from baseline through surgery +24 hours to post 7 days (+/- 2 days)

Study Arms (6)

Phase 1 Group 1 Vertebroplasty

EXPERIMENTAL

Vertebroplasty

Procedure: Vertebroplasty

Phase 1 Group 2 Kyphoplasty

EXPERIMENTAL

Kyphoplasty

Procedure: Kyphoplasty

Phase 2 Group 1 Vertebroplasty

ACTIVE COMPARATOR

Vertebroplasty

Procedure: Vertebroplasty

Phase 2 Group 2 Vertebroplasty + Cavity SpineWand

ACTIVE COMPARATOR

Vertebroplasty with Cavity SpineWand

Procedure: Vertebroplasty; Device: Cavity SpineWand

Phase 2 Group 3 Kyphoplasty

ACTIVE COMPARATOR

Kyphoplasty

Procedure: Kyphoplasty

Phase 2 Group 4 Kyphoplasty + Cavity SpineWand

ACTIVE COMPARATOR

Kyphoplasty with Cavity SpineWand

Procedure: Kyphoplasty; Device: Cavity SpineWand

Interventions

Kyphoplasty PROCEDURE

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.

Phase 1 Group 2 Kyphoplasty; Phase 2 Group 3 Kyphoplasty; Phase 2 Group 4 Kyphoplasty + Cavity SpineWand

Vertebroplasty PROCEDURE

Medical cement will be injected into broken back bone.

Phase 1 Group 1 Vertebroplasty; Phase 2 Group 1 Vertebroplasty; Phase 2 Group 2 Vertebroplasty + Cavity SpineWand

Cavity SpineWand DEVICE

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 2 Group 2 Vertebroplasty + Cavity SpineWand; Phase 2 Group 4 Kyphoplasty + Cavity SpineWand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• ArthroCare Corporation: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Neoplasms; Spinal Diseases

Interventions

Kyphoplasty; Vertebroplasty

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cementoplasty; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Results Point of Contact

• Title: Dawid Schellingerhout, MD/Asst. Professor
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Dawid Schellingerhout, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 9, 2009
• Study Start: December 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 24, 2023
• Results First Posted: December 16, 2010

Record last verified: 2023-03

Locations

US (1)