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

Primary Purpose

Head and Neck Cancer

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Radiotherapy

Align RT

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

radiation therapy arm

Arm Description

Outcomes

Primary Outcome Measures

We are measuring how much a patient moves during treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT01011842

First Posted

November 9, 2009

Last Updated

April 5, 2019

Sponsor

Stanford University

Collaborators

Varian Medical Systems

1. Study Identification

Unique Protocol Identification Number

NCT01011842

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Study Start Date

October 2009 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Varian Medical Systems

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

radiation therapy arm

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Radiation therapy, radiation oncology

Intervention Description

Standard of care

Intervention Type

Procedure

Intervention Name(s)

Align RT

Other Intervention Name(s)

Image-Guided Radiation Therapy

Intervention Description

Standard of care

Primary Outcome Measure Information:

Title

We are measuring how much a patient moves during treatment.

Time Frame

This information will be available immediately have the patient is treated.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Quynh-Thu Le

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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