Radiation Induced Cardiopulmonary Injury in Humans

NCT ID: NCT02259452

Last Updated: 2020-02-26

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

TERMINATED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Thoracic Pulmonary Injury Heart Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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SPECT Lung Perfusion Scan

Intervention Type PROCEDURE

SPECT Heart Perfusion Scan

Intervention Type PROCEDURE

Pulmonary Function Tests

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Wang, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Locations

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University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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LCCC0808

Identifier Type: -

Identifier Source: org_study_id

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