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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018147
• Other study ID #: MCC-10395
• Secondary ID: HM-10395CDR00006
• Status: Completed
• Phase: N/A
• First received: November 20, 2009
• Last updated: February 4, 2016
• Start date: September 2006
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 2015
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• 4-dimensional computed tomography
Undergo 4-D CT imaging

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 1 mm reduction in overall systematic error corresponding with = 2 mm CTV-PTV margin reduction		Up to 7 years	No
Primary	At least 5 Gy reduction in mean lung dose		up to 7 years	No
Primary	At least 5% reduction in absolute pneumonitis risk (= grade 2)		up to 7 years	No

External Links

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