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Radiation Induced Cardiopulmonary Injury in Humans

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ClinicalTrials.gov Identifier: NCT02259452
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : July 9, 2018
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Brief Summary:
The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.

Condition or disease Intervention/treatment
Thoracic Pulmonary Injury Heart Injuries Procedure: SPECT Lung Perfusion Scan Procedure: SPECT Heart Perfusion Scan Procedure: Pulmonary Function Tests

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiation Induced Cardiopulmonary Injury in Humans
Study Start Date : June 2008
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019



Primary Outcome Measures :
  1. Changes in Regional Lung Function [ Time Frame: Up to 4 years post CRT ]
  2. Changes in Regional Heart Function [ Time Frame: Up to 4 years post CRT ]
  3. Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes [ Time Frame: Up to 4 years post CRT ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are to receive 3D-planned RT for lung cancer (conformal or IMRT) or other tumors in/around the thorax.
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Patients who are to receive 3D-planned RT for tumor within and around the thorax.
  3. Patients receiving incidental RT to portions of the heart are eligible.
  4. Estimated minimum expected life expectancy of one year
  5. Able to undergo the required study-related tests for regional lung injury and regional heart injury
  6. Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study.
  7. Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

Exclusion Criteria:

  1. Patients who are anticipated to have thoracic surgery post-RT are ineligible.
  2. Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
  3. Pregnant or nursing women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259452


Locations
United States, North Carolina
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Lawrence Marks, MD University of North Carolina at Chapel Hill, Department of Radiation Oncology

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02259452     History of Changes
Other Study ID Numbers: LCCC0808
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 2018

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Radiation Therapy

Additional relevant MeSH terms:
Wounds and Injuries
Heart Injuries
Lung Injury
Thoracic Injuries
Lung Diseases
Respiratory Tract Diseases