Working... Menu
Trial record 21 of 4293 for:    bone tumors AND NOT metastatic

Vascular CT Assessment of Structural Autograft and Allograft Healing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00594776
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : February 9, 2016
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Eddie Schwarz, University of Rochester

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

Condition or disease Intervention/treatment
Bone Tumors Device: Cone Beam CT Scan

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular CT Assessment of Structural Autograft and Allograft Healing
Study Start Date : November 2006
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in intramedullary vascular volume and new bone growth based on CBCT [ Time Frame: 2, 8 & 18 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00594776

Layout table for location information
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Layout table for investigator information
Principal Investigator: Edward Schwarz, PhD University of Rochester

Layout table for additonal information
Responsible Party: Eddie Schwarz, Professor, University of Rochester Identifier: NCT00594776     History of Changes
Other Study ID Numbers: 15198
P50AR054041 ( U.S. NIH Grant/Contract )
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016

Keywords provided by Eddie Schwarz, University of Rochester:
Cone Beam CT
Bone Tumors

Additional relevant MeSH terms:
Layout table for MeSH terms
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases