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Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms, Neoplasm Metastasis

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Trial Information

Quantifying Radiation Induced Changes in Pulmonary Function in Irradiated and Non-irradiated Lung Tissue


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Spirometry correlated to lung expansion maps

Outcome Time Frame:

3 months post radiation

Safety Issue:

No

Principal Investigator

John Bayouth, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Iowa

Authority:

United States: Institutional Review Board

Study ID:

200905703

NCT ID:

NCT01039649

Start Date:

June 2009

Completion Date:

December 2014

Related Keywords:

  • Lung Neoplasms
  • Neoplasm Metastasis
  • radiation
  • Tomography, Spiral Computed
  • Four-Dimensional Computed Tomography
  • Respiratory Function Tests
  • Neoplasms
  • Lung Neoplasms
  • Neoplasm Metastasis

Name

Location

University of Iowa Department of Radiation Oncology Iowa City, Iowa  52242