Back to resultsDevelopment of Real-time Image-guided Radiotherapy
Primary Purpose
Breast Cancer, Lung Cancer, Skin Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image guided radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Temple University Hospital
Outcomes
Primary Outcome Measures
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).
Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy
Secondary Outcome Measures
To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
Align 4D surface images with internal structures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03524248
Brief Title
Development of Real-time Image-guided Radiotherapy
Official Title
Development of Real-time Image-guided Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Camera for study is being repaired
Study Start Date
May 17, 2012 (Actual)
Primary Completion Date
July 16, 2018 (Actual)
Study Completion Date
July 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Lung Cancer, Skin Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
159 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
Image guided radiation therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
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).
Description
Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy
Time Frame
12 years
Secondary Outcome Measure Information:
Title
To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images
Description
Align 4D surface images with internal structures
Time Frame
12 years
Other Pre-specified Outcome Measures:
Title
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
Description
Synchronization of 4D CBCT with real time stereovision
Time Frame
12 years
Title
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
Description
Validation
Time Frame
12 years
Title
To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy
Description
Determine delivery dose distribution at the site or radiotherapy
Time Frame
12 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development of Real-time Image-guided Radiotherapy
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