This trial is active, not recruiting.

Conditions lung neoplasms, neoplasm metastasis
Sponsor University of Iowa
Start date June 2009
End date June 2013
Trial size 30 participants
Trial identifier NCT01039649, 200905703


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Patients with tumors in the lung that require radiation therapy

Primary Outcomes

Spirometry correlated to lung expansion maps
time frame: 3 months post radiation

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue
Principal investigator John Bayouth, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by University of Iowa.