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OpenTrials
Completed

NCT Number: NCT01039649

A Study to Test Lung Function After Radiation Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Department of Radiation Oncology

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Spirometry correlated to lung expansion maps

    Time frame: 3 months post radiation

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

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

Acronym: PFS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Dec 25, 2009
Registry last updated
Jan 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.