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

18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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


- Quantify the magnitude and distribution of inter- and intrafraction anatomic
variations, including the temporal stability of the tumor/respiration signal

- 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

- 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.

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

At least 1 mm reduction in overall systematic error corresponding with ≥ 2 mm CTV-PTV margin reduction

Outcome Time Frame:

Up to 7 years

Safety Issue:


Principal Investigator

Jeffrey F. Williamson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massey Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2006

Completion Date:

June 2019

Related Keywords:

  • Lung Cancer
  • 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
  • Lung Neoplasms