Development of Real-time Image-guided Radiotherapy

NCT03524248 — Not applicable, Terminated, 159 participants, Fox Chase Cancer Center

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Registry	NCT03524248
Status	Terminated - Camera for study is being repaired
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	159 (Actual)
Sponsor	Fox Chase Cancer Center (Other)
Conditions	Breast Cancer, Lung Cancer, Skin Cancer
Interventions	Image guided radiation therapy (Radiation)
Dates	start 2012-05-17, primary completion 2018-07-16, completion 2018-07-19, first posted 2018-05-14, last updated 2020-03-02
Locations	1 site in United States

-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.

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+Arms and interventions

Image guided radiation therapy (Radiation): 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).

+Outcome measures

Primary outcomes

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 outcomes

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 outcomes

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
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
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

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Temple University Hospital	Philadelphia, Pennsylvania	United States