A Study to Test Lung Function After Radiation Therapy (PFS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John M. Buatti, University of Iowa
ClinicalTrials.gov Identifier:
NCT01039649
First received: December 23, 2009
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition
Lung Neoplasms
Neoplasm Metastasis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Spirometry correlated to lung expansion maps [ Time Frame: 3 months post radiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Lung Radiation
Patients with tumors in the lung that require radiation therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer patients with lung disease requiring radiation therapy. Lung tumor may be lung cancer or metastasis to the lung. Radiation simulation method must be four-dimensional computer tomography (4D-CT)

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039649

Locations
United States, Iowa
University of Iowa Department of Radiation Oncology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: John Bayouth, Ph.D. University of Iowa
Principal Investigator: Johm M. Buatti, M.D. University of Iowa
  More Information

No publications provided

Responsible Party: John M. Buatti, Professor and Chair, Radiation Oncology, University of Iowa
ClinicalTrials.gov Identifier: NCT01039649     History of Changes
Other Study ID Numbers: 200905703
Study First Received: December 23, 2009
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
radiation
Tomography, Spiral Computed
Four-Dimensional Computed Tomography
Respiratory Function Tests

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014