Vascular CT Assessment of Structural Autograft and Allograft Healing

Bone Tumors Clinical Trial

Official title:

Vascular CT Assessment of Structural Autograft and Allograft Healing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00594776
• Other study ID #: 15198
• Secondary ID: P50AR054041
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: February 8, 2016
• Start date: November 2006
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 100 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intramedullary vascular volume and new bone growth based on CBCT		2, 8 & 18 months	No