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Development of Real-time Image-guided Radiotherapy

Sponsor
Fox Chase Cancer Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03524248
Collaborator
(none)
159
Enrollment
1
Location
74.1
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Image guided radiation therapy
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of Real-time Image-guided Radiotherapy
Actual Study Start Date :
May 17, 2012
Actual Primary Completion Date :
Jul 16, 2018
Actual Study Completion Date :
Jul 19, 2018

Outcome Measures

Primary Outcome Measures

  1. 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). [12 years]

    Real time 4-D video imaging in combination with CBCT to detect appropriate delivery of radiotherapy

Secondary Outcome Measures

  1. To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images [12 years]

    Align 4D surface images with internal structures

Other Outcome Measures

  1. 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 [12 years]

    Synchronization of 4D CBCT with real time stereovision

  2. 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 [12 years]

    Validation

  3. To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy [12 years]

    Determine delivery dose distribution at the site or radiotherapy

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Temple University Hospital Philadelphia Pennsylvania United States 19140

Sponsors and Collaborators

  • Fox Chase Cancer Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT03524248
Other Study ID Numbers:
  • 16-6006
First Posted:
May 14, 2018
Last Update Posted:
Mar 2, 2020
Last Verified:
Feb 1, 2020
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
Additional relevant MeSH terms:
Skin Neoplasms

Study Results

No Results Posted as of Mar 2, 2020