Radiation Induced Cardiopulmonary Injury in Humans

February 24, 2020 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

91

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill, Department of Radiation Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Regional Lung Function
Time Frame: Up to 4 years post CRT
Up to 4 years post CRT
Changes in Regional Heart Function
Time Frame: Up to 4 years post CRT
Up to 4 years post CRT
Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes
Time Frame: Up to 4 years post CRT
Up to 4 years post CRT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 13, 2018

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 3, 2014

First Posted (Estimate)

October 8, 2014

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 24, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC0808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thoracic

Clinical Trials on SPECT Lung Perfusion Scan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe