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

April 5, 2019 updated by: Quynh-Thu Le, Stanford University

Comparison of Intrafraction Motion in Patients With Head and Neck Cancer Using Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tracking

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

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

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Image-Guided Radiation Therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Varian Medical Systems

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

October 1, 2009

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

November 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (ESTIMATE)

November 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 5, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-16791
  • SU-09082009-3800 (OTHER: Stanford University)
  • ENT0028 (OTHER: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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