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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2015-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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CT Imaging

Patients undergo 4-D, 4-dimensional computed tomography, CT imaging prior to radiotherapy sessions and once a week at the end of treatment.

Group Type EXPERIMENTAL

4-dimensional computed tomography

Intervention Type PROCEDURE

Undergo 4-D CT imaging

Interventions

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4-dimensional computed tomography

Undergo 4-D CT imaging

Intervention Type PROCEDURE

Other Intervention Names

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4D-CT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No