Radiation Induced Cardiopulmonary Injury in Humans

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02259452

Enrollment

Registered

2014-10-08

Start date

2008-06-30

Completion date

Unknown

Last updated

2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic, Pulmonary Injury, Heart Injuries

Keywords

Radiation Therapy

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.

Interventions

PROCEDURESPECT Lung Perfusion Scan

PROCEDURESPECT Heart Perfusion Scan

PROCEDUREPulmonary Function Tests

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026