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Radiation Induced Cardiopulmonary Injury in Humans

NCT02259452 — Terminated, 91 participants, UNC Lineberger Comprehensive Cancer Center
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RegistryNCT02259452
StatusTerminated - Decision to not gather further data
Study typeObservational
Enrollment91 (Actual)
SponsorUNC Lineberger Comprehensive Cancer Center (Other)
ConditionsThoracic, Pulmonary Injury, Heart Injuries
InterventionsSPECT Lung Perfusion Scan, SPECT Heart Perfusion Scan, Pulmonary Function Tests (Procedure)
Datesstart 2008-06-01, primary completion 2018-04-13, first posted 2014-10-08, last updated 2020-02-26
Locations1 site in United States

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-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.

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+Arms and interventions

  • SPECT Lung Perfusion Scan (Procedure)
  • SPECT Heart Perfusion Scan (Procedure)
  • Pulmonary Function Tests (Procedure)

+Outcome measures

Primary outcomes

  • Changes in Regional Lung Function [Up to 4 years post CRT]
  • Changes in Regional Heart Function [Up to 4 years post CRT]
  • Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes [Up to 4 years post CRT]

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
University of North Carolina at Chapel Hill, Department of Radiation OncologyChapel Hill, North CarolinaUnited States

+Investigators

  • Kyle Wang, MD, Principal investigator, University of North Carolina at Chapel Hill, Department of Radiation Oncology

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