A Study to Test Lung Function After Radiation Therapy (PFS)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
John M. Buatti, University of Iowa
First received: December 23, 2009
Last updated: April 17, 2013
Last verified: April 2013
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue
Primary Outcome Measures:
- Spirometry correlated to lung expansion maps [ Time Frame: 3 months post radiation ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2013 (Final data collection date for primary outcome measure)
Patients with tumors in the lung that require radiation therapy
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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)
- 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
- 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.
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
|University of Iowa Department of Radiation Oncology
|Iowa City, Iowa, United States, 52242 |
University of Iowa
||John Bayouth, Ph.D.
||University of Iowa
||Johm M. Buatti, M.D.
||University of Iowa
No publications provided
||John M. Buatti, Professor and Chair, Radiation Oncology, University of Iowa
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 23, 2009
||April 17, 2013
||United States: Institutional Review Board
Keywords provided by University of Iowa:
Tomography, Spiral Computed
Four-Dimensional Computed Tomography
Respiratory Function Tests
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2014
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases