A Study to Test Lung Function After Radiation Therapy

Completed

• Conditions: Lung Neoplasms; Neoplasm Metastasis

• Registration Number: NCT01039649
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-12-23
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Primary Completion: 2013-06
• Study Completion: 2013-12
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-16
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spirometry correlated to lung expansion maps	3 months post radiation

Trial Locations

Locations (1)

University of Iowa Department of Radiation Oncology; 🇺🇸 Iowa City, Iowa, United States