A Study to Test Lung Function After Radiation Therapy (PFS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Iowa
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
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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
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 May 16, 2013