Radiation Induced Cardiopulmonary Injury in Humans

Thoracic Clinical Trial

Official title:

Radiation Induced Cardiopulmonary Injury in Humans

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02259452
• Other study ID #: LCCC0808
• Status: Terminated
• Start date: June 2008

Study information

• Verified date: February 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. primary completion date: April 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Injuries
• Lung Injury
• Pulmonary Injury
• Thoracic
• Wounds and Injuries

Intervention

Procedure:
• SPECT Lung Perfusion Scan

• SPECT Heart Perfusion Scan

• Pulmonary Function Tests

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill, Department of Radiation Oncology	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Regional Lung Function		Up to 4 years post CRT
Primary	Changes in Regional Heart Function		Up to 4 years post CRT
Primary	Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes		Up to 4 years post CRT