A Study to Test Lung Function After Radiation Therapy

NCT ID: NCT01039649

Last Updated: 2015-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Neoplasms Neoplasm Metastasis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Lung Radiation

Patients with tumors in the lung that require radiation therapy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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John M. Buatti

Professor and Chair, Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Bayouth, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Johm M. Buatti, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Department of Radiation Oncology

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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200905703

Identifier Type: -

Identifier Source: org_study_id

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