Radiation Induced Cardiopulmonary Injury in Humans

NCT02259452 | Terminated DMC

• 1 other identifier: LCCC0808
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic; Pulmonary Injury; Heart Injuries

Keywords

Radiation Therapy

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

SPECT Lung Perfusion Scan PROCEDURE

SPECT Heart Perfusion Scan PROCEDURE

Pulmonary Function Tests PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥ 18 years
• Patients who are to receive 3D-planned RT for tumor within and around the thorax.
• Patients receiving incidental RT to portions of the heart are eligible.
• Estimated minimum expected life expectancy of one year
• Able to undergo the required study-related tests for regional lung injury and regional heart injury
• 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.
• Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment.

You may not qualify if:

• Patients who are anticipated to have thoracic surgery post-RT are ineligible.
• Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function
• Pregnant or nursing women.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Lung Injury; Heart Injuries

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Kyle Wang, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: June 1, 2008
• Primary Completion: April 13, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

US (1)