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Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking for Head & Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01011842
Recruitment Status : Terminated
First Posted : November 11, 2009
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine if a new optical system that can track a patient's movement during treatment can be used to measure motion and allow for motion adjustments in order to decrease the amount of healthy tissue that receives radiation without limiting our ability to cure cancers using radiation.

Condition or disease Intervention/treatment
Head and Neck Cancer Procedure: Radiotherapy Procedure: Align RT

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: radiation therapy arm Procedure: Radiotherapy
Standard of care
Other Names:
  • Radiation therapy
  • radiation oncology
Procedure: Align RT
Standard of care
Other Name: Image-Guided Radiation Therapy

Outcome Measures

Primary Outcome Measures :
  1. We are measuring how much a patient moves during treatment. [ Time Frame: This information will be available immediately have the patient is treated. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with HNC undergoing radiation therapy at Stanford University
  • Age >= 18 years old
  • Radiation course >= 4 weeks duration
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Factors such as claustrophobia inhibiting use of thermoplastic mask immobilization device.
  • Patients who are pregnant or nursing, which preclude them from undergoing active radiation treatment.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01011842

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Varian Medical Systems
Principal Investigator: Quynh-Thu Le Stanford University
More Information

Responsible Party: Quynh-Thu Le, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01011842     History of Changes
Other Study ID Numbers: ENT0028
SU-09082009-3800 ( Other Identifier: Stanford University )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site