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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: 4-dimensional computed tomography

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 4-dimensional computed tomography; Undergo 4-D CT imaging; Other Names: 4D-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction	Up to 7 years
At least 5 Gy reduction in mean lung dose	up to 7 years
At least 5% reduction in absolute pneumonitis risk (≥ grade 2)	up to 7 years

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey F. Williamson, PhD, Massey Cancer Center

Publications and helpful links

Helpful Links

• published article
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• This article has been featured in: http://biomedfrontiers.org/cancer-2014-2-4/
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Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: November 20, 2009
• First Submitted That Met QC Criteria: November 20, 2009
• First Posted (ESTIMATE): November 23, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): February 8, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IA non-small cell lung cancer; stage IB non-small cell lung cancer; stage IIA non-small cell lung cancer; stage IIB non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MCC-10395; HM-10395 (OTHER: VCU IRB); CDR0000657239 (REGISTRY: PDQ (Physician Data Query)); NCI-2011-01700 (REGISTRY: CTRP (Clinical Trials Reporting System))