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Vascular CT Assessment of Structural Autograft and Allograft Healing

This study is currently recruiting participants.
Verified December 2012 by University of Rochester
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT00594776
First received: January 7, 2008
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.


Condition Intervention
Bone Tumors
 Device: Cone Beam CT Scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular CT Assessment of Structural Autograft and Allograft Healing

Resource links provided by NLM:

MedlinePlus related topics: Bone Cancer Cancer
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in intramedullary vascular volume and new bone growth based on CBCT [ Time Frame: 2, 8 & 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Patients who have received a structrual allograft or vascularized fibular autograft surgery to reconstruct their tibia, femur, ulna/radius or humerus for treatment of a bone tumor.
 Device: Cone Beam CT Scan
The Cone Beam Computerized Tomographic (CBCT) device utilizes computerized tomographic technology, a special digital imaging plate and a computer to create a three-dimensional image. The special imaging plate and software allow for small details to be imaged without tissue overlap.

Detailed Description:

The purpose of this study is to investigate quantitative vascular cone beam CT(CBCT) in a clinical pilot of patients that have received a structural allograft for bone cancer or a vascularized structural autograft for bone cancer or traumatic injury. Development of a minimally invasive, longitudinal outcome measure to quantify intramedullary vascular volume and cortical bone volume of structural allografts in patients is required to translate "revitalizing" structural allograft in clinical trials. Our novel vascular CBCT will be able to demonstrate the significant differences between vascularized fibular autografts vs. structural allografts in patients that will undergo structural grafting. These data will be used to devise a power calculation for a definitive clinical trial to evaluate the efficacy of the revitalizing allograft.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are recruited from the general practice of 3 of our investigators. Patients will have received an structural allograft or vascularized autograft for the treatment of bone cancer.

Criteria

Inclusion Criteria:

  • male or female
  • all races will be included
  • autograft or allograft of long bone as part of treatment for bone tumor

Exclusion Criteria:

  • pregnancy
  • patients with a history of IV contrast reactions
  • contraindication to use of epinephrine or diphenhydramine
  • hypertyroidism or history of sensitivity to iodine
  • kidney disease (abnormal urinalysis or calculaged GFR) or poor hydration due to poor intake or other causes
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594776

Contacts
Contact: Allison W McIntyre, MPH 585-341-9304 Allisonw_mcintyre@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Allison W McIntryre, MPH     585-341-9304     allisonw_mcintyre@urmc.rochester.edu    
Sub-Investigator: Randy Rosier, MD, PhD            
Sub-Investigator: Regis O'Keefe, MD, PhD            
Sub-Investigator: David Mitten, MD            
Sub-Investigator: Susan Bukata, MD            
Sub-Investigator: R. John Looney, MD            
Sub-Investigator: Christoher Beck, PhD            
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
Investigators
Principal Investigator: Edward Schwarz, PhD University of Rochester
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT00594776     History of Changes
Other Study ID Numbers: 15198, P50AR054041
Study First Received: January 7, 2008
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Cone Beam CT
CBCT
Bone Tumors
Autographs
Allographs

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on June 18, 2013