4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition

This clinical trial studies 4-dimensional (4-D) image-guided radiation therapy treatment planning in patients with stage I-IV non-small cell lung cancer. Computed tomography (CT) scans and treatment-planning systems may help in planning radiation therapy for patients with non-small cell lung cancer. This is not a therapy study. Therefore no direct benefit from participating is expected. However, at the discretion of the treating physician, the information gained from the additional imaging will be used to improve treatment accuracy. No patient outcome data are gathered or analyzed by this study. This study is not a:Phase I, II, or III trial, trial with "blinded" treatment arm, gene or a vaccine trial, or a multi-institutional trial.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

OBJECTIVES:

Quantify the magnitude and distribution of inter- and intrafraction anatomic variations, including the temporal stability of the tumor/respiration signal correlation.
Improve the acquisition and reconstruction of 4D CT scan images by advancing the 4D CT scan data collection process and evaluating 4D CT scan image reconstruction using different respiratory inputs.
Quantify the uncertainty of deformable image-registration algorithms.
Develop and investigate the efficacy of inter- and intrafraction probabilistic planning-based 4D image-guided adaptive radiotherapy (IGART) strategies for clinical application.
Determine the expected geometric, dosimetric, and radiobiological improvements from the 4D IGART system.

OUTLINE: Patients undergo insertion of ≥ 1 small radio-opaque marker into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. X-rays are performed to document the position of the markers.

Patients undergo 4D CT scan before each radiotherapy session and once a week after a radiotherapy session. Patients also undergo x-ray imaging before and during radiotherapy, optical and internal marker motion recording before and after radiotherapy, and audiovisual feedback during radiotherapy.

Patients undergo image-guided adapted radiotherapy based on these data.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histologic or cytologic confirmation of non-small cell lung cancer stages I-IV
Partial pressure oxygen (pO2) > 92%-obtained at the time of or within 3 months prior to initial consultation with the radiation oncologist
Tumor(s) must be visualized on a CT
Positron emission tomography (PET) is performed during staging or treatment planning process
All patients must be informed on the investigational nature of this study and must give informed consent in accordance with institutional guidelines

Exclusion criteria

Pregnant women may not participate; women of reproductive potential must be informed of the need to practice an effective contraceptive method
Unstable coronary artery disease
Uncorrectable coagulopathy
Severe pulmonary hypertension
Poor tolerance of conscious sedation

Treatment and study plan

4-Dimensional Computed Tomography

Procedure

Undergo 4-D CT imaging

Other names: 4D-CT

Primary outcomes

At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction

Time frame: Up to 7 years
At least 5 Gy reduction in mean lung dose

Time frame: up to 7 years
At least 5% reduction in absolute pneumonitis risk (≥ grade 2)

Time frame: up to 7 years

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Important dates

Study start: 2006
Primary completion: 2012
Study completion: 2015
First posted: Nov 23, 2009
Registry last updated: Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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