Development of Real-time Image-guided Radiotherapy

NCT03524248 | Terminated

• 1 other identifier: 16-6006
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Lung Cancer; Skin Cancer

Outcome Measures

Primary Outcomes (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).

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

  12 years

Secondary Outcomes (1)

• To correlate real-time 4D surface images with the internal structures shown in daily XVI volumetric images

  12 years

Other Outcomes (3)

• 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

• 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

• To determine delivery dose distribution by correlating real-time surface images with the planning volumetric images and dose distribution for radiotherapy

  12 years

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Skin Neoplasms

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: May 17, 2012
• Primary Completion: July 16, 2018
• Study Completion: July 19, 2018
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)