- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00594776
Vascular CT Assessment of Structural Autograft and Allograft Healing
February 8, 2016 updated by: Eddie Schwarz, University of Rochester
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
8
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14642
- University of Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 100 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in intramedullary vascular volume and new bone growth based on CBCT
Time Frame: 2, 8 & 18 months
|
2, 8 & 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Edward Schwarz, PhD, University of Rochester
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 7, 2008
First Submitted That Met QC Criteria
January 7, 2008
First Posted (Estimate)
January 16, 2008
Study Record Updates
Last Update Posted (Estimate)
February 9, 2016
Last Update Submitted That Met QC Criteria
February 8, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15198
- P50AR054041 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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