ThoracicNCT02259452
Radiation Induced Cardiopulmonary Injury in Humans
An observational study of Thoracic and Pulmonary Injury, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic, Pulmonary Injury, Heart Injuries
- What is being tested?
- SPECT Lung Perfusion Scan, SPECT Heart Perfusion Scan and Pulmonary Function Tests
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to 13 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are to receive 3D-planned RT for lung cancer (conformal or IMRT) or other tumors in/around the thorax.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill, Department of Radiation Oncology
Chapel Hill, North Carolina, 27599
About this study
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
- Being tested
- SPECT Lung Perfusion Scan, SPECT Heart Perfusion Scan, Pulmonary Function Tests
- Keywords
- Radiation Therapy
- Medical subject headings
- Lung Injury, Heart Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT Lung Perfusion ScanProcedure or surgery
SPECT Heart Perfusion ScanProcedure or surgery
Pulmonary Function TestsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Regional Lung Function
Measured: Up to 4 years post CRT
Changes in Regional Heart Function
Measured: Up to 4 years post CRT
Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes
Measured: Up to 4 years post CRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startJun 2008
- Primary completion13 Apr 2018
Why it stopped: Decision to not gather further data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThoracicStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Wang, MD, Principal investigator, University of North Carolina at Chapel Hill, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259452
- Sponsor's protocol ID
- LCCC0808
- Status last verified
- Feb 2020
- First submitted
- 3 Oct 2014
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiation Induced Cardiopulmonary Injury in Humans
- ClinicalTrials.gov ID
- NCT02259452
- Acronym / sponsor ID
- LCCC0808
- Conditions
- Thoracic, Pulmonary Injury, Heart Injuries
- Keywords
- Radiation Therapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Decision to not gather further data
- Enrolment
- 91 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- 13 Apr 2018 (actual)
- First posted
- 8 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are to receive 3D-planned RT for lung cancer (conformal or IMRT) or other tumors in/around the thorax.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT Lung Perfusion Scan | Procedure or surgery | – |
| SPECT Heart Perfusion Scan | Procedure or surgery | – |
| Pulmonary Function Tests | Procedure or surgery | – |
Primary outcome
Changes in Regional Lung Function
Time frame: Up to 4 years post CRT
Changes in Regional Heart Function
Time frame: 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
Results and safety
The study was stopped early (reason given: Decision to not gather further data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Wang, MD principal investigator
University of North Carolina at Chapel Hill, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic and Pulmonary Injury, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Decision to not gather further data). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Regional Lung Function (time frame: Up to 4 years post CRT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.