A Study to Test Lung Function After Radiation Therapy

Neoplasm Metastasis Clinical Trial

— PFS  

Official title:

Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01039649
• Other study ID #: 200905703
• Status: Completed
• Phase: N/A
• First received: December 23, 2009
• Last updated: January 16, 2015
• Start date: June 2009
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms

Locations

Country	Name	City	State
United States	University of Iowa Department of Radiation Oncology	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry correlated to lung expansion maps		3 months post radiation	No