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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01039649
Recruitment Status : Completed
First Posted : December 25, 2009
Last Update Posted : January 19, 2015
Information provided by (Responsible Party):
John M. Buatti, University of Iowa

Brief Summary:
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.

Condition or disease
Lung Neoplasms Neoplasm Metastasis

Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue
Study Start Date : June 2009
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Lung Radiation
Patients with tumors in the lung that require radiation therapy

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: John M. Buatti, Professor and Chair, Radiation Oncology, University of Iowa Identifier: NCT01039649     History of Changes
Other Study ID Numbers: 200905703
First Posted: December 25, 2009    Key Record Dates
Last Update Posted: January 19, 2015
Last Verified: January 2015

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

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes