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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
  Purpose
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.

Condition Intervention
Lung Cancer
Procedure: 4-dimensional computed tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 4D Image-guided Adaptive Radiotherapy for Lung Cancer: Patient Image Acquisition

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: September 2006
Study Completion Date: October 2015
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 4D-CT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018147

Sponsors and Collaborators
Virginia Commonwealth University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jeffrey F. Williamson, PhD Massey Cancer Center
  More Information

Additional Information:
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01018147     History of Changes
Other Study ID Numbers: MCC-10395  HM-10395  CDR0000657239  NCI-2011-01700 
Study First Received: November 20, 2009
Last Updated: February 4, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
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:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2016