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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01018147
First received: November 20, 2009
Last updated: April 10, 2014
Last verified: April 2014
  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.


Condition Intervention
Lung Cancer
Radiation: radiation therapy treatment planning/simulation
Procedure: 4-dimensional computed tomography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (radiation therapy planning)
Patients undergo placement of one or more small radio-opaque markers or electromagnetic transponders into (or in the vicinity of) the primary lesion or suspect lymph nodes via bronchoscopy. Patients then undergo 4-D CT imaging prior to radiotherapy sessions and once a week at the end of treatment.
Radiation: radiation therapy treatment planning/simulation
Undergo 4-D CT imaging
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018147

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

Additional Information:
No publications provided

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: April 10, 2014
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 April 17, 2014