A Study to Test Lung Function After Radiation Therapy

NCT01039649 | Completed DMC

• 1 other identifier: 200905703
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Neoplasms; Neoplasm Metastasis

Keywords

radiation; Tomography, Spiral Computed; Four-Dimensional Computed Tomography; Respiratory Function Tests

Outcome Measures

Primary Outcomes (1)

• Spirometry correlated to lung expansion maps

  3 months post radiation

Study Arms (1)

Lung Radiation

Patients with tumors in the lung that require radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Department of Radiation Oncology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• John Bayouth, Ph.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Johm M. Buatti, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Radiation Oncology

Study Record Dates

• First Submitted: December 23, 2009
• First Posted: December 25, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: January 19, 2015

Record last verified: 2015-01

Locations

US (1)