Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification

This study has been completed.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center. Identifier:
First received: December 20, 2007
Last updated: February 5, 2014
Last verified: February 2014

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.

Condition Intervention
Radiation Treatment for Tumors
Other: Cone Beam Imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Cone Beam Imaging for Radiation Therapy Treatment Verification

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Compare the quality and utility of the MV and kV conebeam systems. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: April 2004
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Prototype, third generation EPID based portal imaging system utilizing the MV approach.
Other: Cone Beam Imaging
Prototype, third generation EPID based portal imaging system utilizing the MV approach.

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00582959

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Principal Investigator: Michael Zelefsky, MD Memorial Sloan Kettering Cancer Center.
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan Kettering Cancer Center. Identifier: NCT00582959     History of Changes
Other Study ID Numbers: 04-037, NCI CA59017
Study First Received: December 20, 2007
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
radiology imaging
undergoing radiation therapy processed this record on March 03, 2015