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A Study to Test Lung Function After Radiation Therapy (PFS)

This study has been completed.
Information provided by (Responsible Party):
John M. Buatti, University of Iowa Identifier:
First received: December 23, 2009
Last updated: January 16, 2015
Last verified: January 2015
It is known that radiation damages lung tissue. New human studies at University of Iowa show that the radiation damage is not as expected. The purpose of this study is to document lung function using four-dimensional computed tomography (CT) and quantify changes three months after radiation therapy for malignant lung disease.

Lung Neoplasms Neoplasm Metastasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue

Resource links provided by NLM:

Further study details as provided by John M. Buatti, University of Iowa:

Primary Outcome Measures:
  • Spirometry correlated to lung expansion maps [ Time Frame: 3 months post radiation ]

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Lung Radiation
Patients with tumors in the lung that require radiation therapy


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients with lung disease requiring radiation therapy. Lung tumor may be lung cancer or metastasis to the lung. Radiation simulation method must be four-dimensional computer tomography (4D-CT)

Inclusion Criteria:

  • Histological diagnosis of small cell or non-small cell lung cancer or metastatic tumor to the lung being scheduled for localized radiation therapy (including radiosurgery)
  • No prior or future planned surgery for the treatment of the lung cancer.
  • Age ≥ 18 years
  • Karnofsky 60%
  • Not pregnant.
  • Ability to understand and the willingness to sign a written informed consent document
  • Ability and willingness to participate in breathing training and compliance wiht breathing apparatus so that radiation doses are optimally linked to 4D-CT images
  • Ability to tolerate CT contrast

Exclusion Criteria:

  • No prior thoracic radiotherapy will be permitted
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women
  • Severe COPD that requires chronic prednisone or multiple inhalers
  • Underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegener's granulomatosis)
  • Oxygen dependence at baseline
  • Recent lung surgery or abdominal surgery (within 3 weeks) that would compromise respiratory pattern.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01039649

United States, Iowa
University of Iowa Department of Radiation Oncology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Principal Investigator: John Bayouth, Ph.D. University of Iowa
Principal Investigator: Johm M. Buatti, M.D. University of Iowa
  More Information

Responsible Party: John M. Buatti, Professor and Chair, Radiation Oncology, University of Iowa Identifier: NCT01039649     History of Changes
Other Study ID Numbers: 200905703
Study First Received: December 23, 2009
Last Updated: January 16, 2015

Keywords provided by John M. Buatti, University of Iowa:
Tomography, Spiral Computed
Four-Dimensional Computed Tomography
Respiratory Function Tests

Additional relevant MeSH terms:
Neoplasm Metastasis
Lung Neoplasms
Neoplastic Processes
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases processed this record on August 17, 2017