Real-Time kV Imaging vs. Real-Time 3D Patient Surface Tra... | NCT01011842

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

NCT01011842

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Apr 9, 2019Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Head and Neck Cancer

Interventions

Radiotherapy
Align RT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
SU-09082009-3800	Other Identifier	Stanford University
ENT0028	Other Identifier	OnCore

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

Mar 2010Actual

Completion Date

Nov 2011Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2019

Last Update Posted Date

Apr 9, 2019Actual

Name	Class
Varian Medical Systems	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiation therapy arm	Experimental		Procedure: Radiotherapy Procedure: Align RT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Procedure	Standard of care	radiation therapy arm	Radiation therapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Quynh-Thu Le	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D011827	Radiation
D061089	Radiotherapy, Image-Guided

Ancestor Terms

ID	Term
D013812	Therapeutics
D055585	Physical Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided