Development of Real-time Image-guided Radiotherapy

February 27, 2020 updated by: Fox Chase Cancer Center
The goal is to achieve the maximal radiotherapy tumor dose while sparing the health tissue and critical structures. On-board cone-beam CT (CBCT) scans are routinely acquired prior to dose delivery and matched with simulation CT at the planned treatment positions. Thus, setup or motion errors can be detected and corrected. However, CBCT is not available for situations with gantry collisions such as WBI and TSEB. More importantly, CBCT cannot reveal any irregular respiration or body movement during beam-on time. Thus, it is essential to develop a real-time image system that can detect organ/body motion during beam-on time, and correlate simulation-planning images with prior treatment CBCT images.In this proposed clinical trial, we will cooperate with a 3D camera company (Xigen LLC) to develop novel 4D video imaging techniques and validate the feasibility and accuracy of 4D video image guidance in correlation with 4D CT/CBCT useful for advanced IGRT.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

159

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital

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:

  • All patients benefit from advanced IGRT can participate to the study except for those emergent and pediatric patients (age <18 years) who require special care or there is no time for the setup the 4D video systems
  • The patient population would be selected according to the technical progress and clinical needs

Exclusion Criteria:

  • None

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
Time Frame: 12 years
Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy
12 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
Time Frame: 12 years
Align 4D surface images with internal structures
12 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To synchronize the 4D CBCT with real-time stereovisions that would allow us to track any irregular respiration motion useful for gated or target tracked radiotherapy
Time Frame: 12 years
Synchronization of 4D CBCT with real time stereovision
12 years
To validate accuracy and precision of the patient position in special procedures such as stereotactic body radiotherapy (SBRT), total skin electron beam therapy (TSEB), IMRT of H&N cancer, and whole-breast irradiation (WBI) under breast holding
Time Frame: 12 years
Validation
12 years
To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy
Time Frame: 12 years
Determine delivery dose distribution at the site or radiotherapy
12 years

Collaborators and Investigators

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

Sponsor

Fox Chase Cancer Center

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 (Actual)

May 17, 2012

Primary Completion (Actual)

July 16, 2018

Study Completion (Actual)

July 19, 2018

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-6006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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