A Study to Test Lung Function After Radiation Therapy

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01039649

Acronym

PFS

Enrollment

Registered

2009-12-25

Start date

2009-06-30

Completion date

2013-12-31

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms, Neoplasm Metastasis

Keywords

radiation, Tomography, Spiral Computed, Four-Dimensional Computed Tomography, Respiratory Function Tests

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Spirometry correlated to lung expansion maps	3 months post radiation

Countries

United States

Outcome results