- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582959
Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification
February 5, 2014 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to test a new technology for obtaining x-ray images of your treatment fields when you are positioned on the treatment machine, to determine whether this new system is as reliable and easy to use as conventional systems..
These so-called portal images are normally taken on a weekly basis, prior to your radiation treatment.
The new portal imaging system to be tested is designed to produce better quality images than are currently achievable, but with no additional dose or added treatment time.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this proposal is to test the clinical practicality of a new technology; cone beam imaging, for verification of treatment set up accuracy of cancer patients receiving radiation therapy.
Currently, treatment accuracy is checked via use of 2-dimensional projection x-rays taken with the megavoltage treatment beam and electronic portal imaging devices (EPID).
Typically 2 orthogonal portal images are obtained to confirm patient positioning accuracy.
This method of treatment verification, however, usually provides images of poor quality and lacks true 3D information, thus making it difficult for the radiation oncologist to definitively confirm treatment accuracy.
New generation EPIDs are capable of obtaining higher quality images at significantly lower imaging doses.
Thus, for the same total imaging dose new generation EPIDs permit acquisition of many projection images rather than just 2 or 3.
The combination of more images and higher quality images should permit more definitive assessment of treatment accuracy.
We propose here to test the clinical practicality and reliability of a new prototype portal imaging system.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
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
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have histologic proof of a malignancy suitable for radiation therapy in order to be eligible for this study
Exclusion Criteria:
- None
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Prototype, third generation EPID based portal imaging system utilizing the MV approach.
|
Prototype, third generation EPID based portal imaging system utilizing the MV approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Obtain multiple (1-5) 3DCBIs on patients during the course of their radiation therapy treatments using a prototype megavoltage (MV) system and determine if the prototype imaging system is reliable and practical for routine clinical portal imaging.
Time Frame: conclusion of the study
|
conclusion of the study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
For some patients, in addition to obtaining 1-5 MV conebeam scans, obtain 1-2 conebeam scans using a new kilovoltage conebeam imaging system
Time Frame: conclusion of the study
|
conclusion of the study
|
|
Compare the quality and utility of the MV and kV conebeam systems.
Time Frame: conclusion of the study
|
conclusion of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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
April 1, 2004
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 27, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Estimate)
February 6, 2014
Last Update Submitted That Met QC Criteria
February 5, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 04-037
- NCI CA59017
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.