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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01018147
First received: November 20, 2009
Last updated: February 4, 2016
Last verified: February 2016

November 20, 2009
February 4, 2016
September 2006
April 2012   (final data collection date for primary outcome measure)
  • At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction [ Time Frame: Up to 7 years ] [ Designated as safety issue: No ]
  • At least 5 Gy reduction in mean lung dose [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
  • At least 5% reduction in absolute pneumonitis risk (≥ grade 2) [ Time Frame: up to 7 years ] [ Designated as safety issue: No ]
  • At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction [ Designated as safety issue: No ]
  • At least 5 Gy reduction in mean lung dose [ Designated as safety issue: No ]
  • At least 5% reduction in absolute pneumonitis risk (≥ grade 2) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01018147 on ClinicalTrials.gov Archive Site
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4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Lung Cancer
Procedure: 4-dimensional computed tomography
Undergo 4-D CT imaging
Other Name: 4D-CT
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.
Intervention: Procedure: 4-dimensional computed tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
October 2015
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01018147
MCC-10395, HM-10395, CDR0000657239, NCI-2011-01700
Yes
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Not Provided
Virginia Commonwealth University
Virginia Commonwealth University
National Cancer Institute (NCI)
Principal Investigator: Jeffrey F. Williamson, PhD Massey Cancer Center
Virginia Commonwealth University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP