Development of Real-time Image-guided Radiotherapy

Breast Cancer Clinical Trial

Official title:

Development of Real-time Image-guided Radiotherapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03524248
• Other study ID #: 16-6006
• Status: Terminated
• Phase: N/A
• Start date: May 17, 2012
• Est. completion date: July 19, 2018

Study information

• Verified date: February 2020
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 159
• Est. completion date: July 19, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Lung Cancer
• Skin Cancer
• Skin Neoplasms

Intervention

Radiation:
• Image guided radiation therapy
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).

Locations

Country	Name	City	State
United States	Temple University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Synchronization of 4D CBCT with real time stereovision	12 years
Other	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	Validation	12 years
Other	To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy	Determine delivery dose distribution at the site or radiotherapy	12 years
Primary	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	12 years
Secondary	To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images	Align 4D surface images with internal structures	12 years