Bone TumorsNCT00594776
Vascular CT Assessment of Structural Autograft and Allograft Healing
An observational study of Bone Tumors, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing. Read more about this study
- Who is it for?
- Ages 10 to 100 years
- Conditions the study is for
- Bone Tumors
- What is being tested?
- Cone Beam CT Scan
- Type of treatment
- Medical device
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- male or female
- all races will be included
- autograft or allograft of long bone as part of treatment for bone tumor
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.
Read the 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.
- Conditions
- Bone Tumors
- Being tested
- Cone Beam CT Scan
- Keywords
- Cone Beam CT, CBCT, Bone Tumors, Autographs, Allographs
- Medical subject headings
- Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam CT ScanDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cone Beam CT Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intramedullary vascular volume and new bone growth based on CBCT
Measured: 2, 8 & 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone TumorsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Eddie Schwarz, University of Rochester
- Investigators
- Edward Schwarz, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594776
- Sponsor's protocol ID
- 15198
- Other IDs
- P50AR054041
- Status last verified
- Feb 2016
- First submitted
- 7 Jan 2008
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular CT Assessment of Structural Autograft and Allograft Healing
- ClinicalTrials.gov ID
- NCT00594776
- Acronym / sponsor ID
- 15198
- Conditions
- Bone Tumors
- Keywords
- Cone Beam CT, CBCT, Bone Tumors, Autographs, Allographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Nov 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Cone Beam CT ScanPatients 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. |
Who may qualify
- Ages
- 10 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- male or female
- all races will be included
- autograft or allograft of long bone as part of treatment for bone tumor
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam CT ScanThe 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. | Device | 1 |
Primary outcome
Change in intramedullary vascular volume and new bone growth based on CBCT
Time frame: 2, 8 & 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Schwarz, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Tumors, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intramedullary vascular volume and new bone growth based on CBCT (time frame: 2, 8 & 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2016.