Real-Time MV/kV Image Guided Radiation Therapy | NCT01260909

Studies
Real-Time MV/kV Image Guided Radiation Therapy

NCT01260909

Sponsor

Stanford University

Status

Withdrawn

Last Update Posted

Dec 2, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Real-time kV/MV Prostate Imaging

Countries

Not provided

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-12132010-7282	Other Identifier	Stanford University
R21CA153587	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business decision

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2015Estimated

Completion Date

Jan 2015Estimated

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 14, 2010

First Posted Date

Dec 15, 2010Estimated

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

Nov 29, 2017

Last Update Posted Date

Dec 2, 2017Actual

Name	Class
National Institutes of Health (NIH)	NIH
National Cancer Institute (NCI)	NIH

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

In current radiation therapy, imaging (typically, cone beam CT imaging or two orthogonal X-ray projection imaging) is done for patient setup before radiation dose delivery. Dose delivery typically takes 2 to 5 minutes depending on the delivery technique used for treatment. A tumor target may change its position during the dose delivery process. The goal of this project is develop a real-time imaging strategy to monitor the tumor position during dose delivery and evaluate its potential clinical impact.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Real-time kV/MV Prostate Imaging			Device: Real-time kV/MV Prostate Imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Real-time kV/MV Prostate Imaging	Device	The kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC).	Real-time kV/MV Prostate Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To verify improved tumor targeting accuracy using IMRT (intensity modulated radiation therapy) and VMAT (volumetric modulated radiation therapy)		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

Exclusion Criteria:

The study population will be drawn from available patient population that will be treated using IMRT/VMAT. The Stanford population of IMRT/VMAT will be taken as roughly representative of prospective IMRT patients and will not be subdivided by any additional characteristics.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

prostate cancer patients at Stanford University

Sampling Method

Probability Sample

Name	Affiliation	Role
Lei Xing	Stanford University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D061089	Radiotherapy, Image-Guided

Ancestor Terms

ID	Term
D011878	Radiotherapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided