Thoracic NeoplasmsNCT01913769
Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan
An observational study of Thoracic Neoplasms and Late Effect of Radiation, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: Chemoradiation is an important treatment strategy of locally advanced inoperable or unresectable disease. Radiation dose is an independent predictor of a pathological response. In addition, chemotherapy has further impact on the aspect of outcome. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Thoracic Neoplasms, Late Effect of Radiation
- What is being tested?
- Thallium-201 Myocardial Perfusion Study
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jul 2016
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with thoracic malignancy who scheduled further locoregional RT.
Who may be able to join
- Patients with thoracic malignancy who scheduled further locoregional RT.
- Aged 20-80 years old.
- Classified as intermediate to high future CV risk clinically.
Who cannot join
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy.
- Any medical contraindication of stress cardiac SPECT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan: Correlation Between Radiotherapy Dose Distribution, Myocardial Perfusion, Cardiac Function, Serum Biomarkers and Clinical Prognosis.
Background:
Chemoradiation is an important treatment strategy of locally advanced inoperable or unresectable disease. Radiation dose is an independent predictor of a pathological response. In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There have been sequential improvements in tumor localization, radiation planning and delivery over the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses associated with increased complications. However, heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The damage of the myocytes may lead to not only myocardial perfusion defects, but also in functional deterioration, or even in biomarkers.
Read more
Since the impact of radiation-induced heart injury in patients with thoracic malignancies (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate of RT-related cardiac effects and clinical impacts.
Objective:
This study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies.
Methods:
The study plans to enroll thoracic cancer patients who will undergo local RT after complete staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image (MPI) at the time points of before and after RT. The results of MPI will be analyzed in qualitative visual interpretation of perfusion patterns, and functional quantitative data for cardiac functional parameters as well. The patients will be regular followed-up in CV OPD, following clinical judgement and guideline. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated.
Expected results:
We will obtain myocardial perfusion visual qualitative data in patients who received locoregional RT, respectively. These results will help in the understanding of pathophysiology, clinical management and follow-up of suspected RT-related heart disease.
Read the detailed description
The risk of RT-related heart disease is now well recognized but the underlying mechanisms of its initiation and progression, and the roles played by microvascular damage, fibrosis and atherosclerosis remain unclear. Studying RT-related heart disease have demonstrated that irradiation affects cardiac structure and microvascular function in a dose and time-dependent manner, with substantial damage after intermediate and high dose irradiation, and minor alterations after lower doses. Not only structural changes but also functional deterioration was noted. Studies disclosing that incidence of post 3D-RT perfusion defect is in approximately 40%, and the patients had volume-dependent perfusion defects within 2 years of RT.
To better evaluation of the RT-related heart disease, we plan to initiate a prospective study trail that takes advantage of recent technical advances in tomotherapy, and new Cadimium-Zinc-Telluride (CZT) cardiac camera.
- Estimated Case Number: 100 patients will be enrolled in the study.
- Patients with thoracic cancer will be transferred to CV OPD for initial cardiovascular risk factors assessment, before starting radiation therapy.
- Past history, family history, basic lab data and Framingham cardiovascular risk assessment will be applied. After approaching risk stratification, patients who were classified as intermediated to high risk need further work-up. Who needs to undergo myocardial perfusion study will be enrolled in the study before further RT course.
- All enrolled subjects provide basic demographic data and sign informed consents.
- Myocardial perfusion images with Tl-201 and CZT camera will be performed in nuclear medicine department of FEMH, completing baseline evaluation before RT.
- The patients received scheduled treatment plan, including RT.
- Follow-up CV OPD based on clinical decision and guideline: blood biochemistry and inflammation marker, CV risk scores. Further work-up would be indicated if functional status deterioration or aggravated symptoms.
- Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.
- Comparing the clinical follow-up data between groups, including global functional assessments, blood sampling data, myocardial perfusion scan, and quantitative cardiac functional parameters.
Blood sampling Peripheral blood will be drawn for measurements of blood glucose, lipid profile, and circulating biomarker of CRP. The genomic tests will not be involved in the study.
Myocardial perfusion study-for quantitative functional parameters, qualitative and quantitative myocardial perfusion scan. Patients referred for SPECT MPI for evaluation of CAD underwent a 1-day Tl-201 stress/rest MPI protocol, as daily practice in FEMH. Pharmacological stress was induced by standard dipyridomale infusion. Tl-201 of 2 mCi was injected after 7 min of induced stress. The software package Myovation for Alcyone (GE Healthcare), QGS and QPS were used for quantitative analysis off MPI polar maps using a 17-segment model for the left ventricle. Automated analysis of gated acquisitions from high-dose (rest) scans was performed to determine left ventricular ejection fraction (LVEF).
Integrated clinical information, follow-up and nuclear medicine cardiac scans performed in the time points of before \& after RT will be collected and analyzed.
- Conditions
- Thoracic Neoplasms, Late Effect of Radiation
- Being tested
- Thallium-201 Myocardial Perfusion Study
- Keywords
- post-RT, myocardial perfusion images
- Medical subject headings
- Thoracic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thallium-201 Myocardial Perfusion StudyRadiation
One-day Tl-201 stress/rest MPI protocol with pharmacological stress, as daily practice will be applied. CZT camera with multipinhole collimator and stationary detectors scan heart simultaneously. A 10% symmetrical energy window at 140 keV was used. Electrocardiogram-gated scans will be applied. Perfusion images were reconstructed in standard axis and polar maps of the left ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers blinded to any information on patient identification. The software package Myovation for Alcyone, QGS and QPS were used for quantitative analysis of MPI polar maps. Automated analysis to determine ejection fraction.
| Study group | Role | What they receive |
|---|---|---|
| Radiation therapy | Thoracic cancer patient s/p scheduled RT will be arranged to undergo Thallium-201 Myocardial Perfusion Study. The scheduled RT will be arranged by clinical judgments of radiation-oncologists. All of the patients will receive myocardial SPECT before and after the scheduled RT. Receives: Radiation: Thallium-201 Myocardial Perfusion Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images
By literature reviewing, cardiovascular functional status in patients received helical tomography has not been fully investigated yet. And the post-therapeutic heart disease tends to show a wide spectrum of pathologies and multiple risk factors. We will monitor risk factors of underlying disease, family history, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineation of RT-related effects and clinical prognosis.
Measured: July, 2014 (after 12 months of baseline study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2014 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic NeoplasmsStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shan-Ying Wang, M.D., Principal investigator, Far Eastern Memorial Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913769
- Sponsor's protocol ID
- FEMH-IRB-102032-F
- Status last verified
- Jul 2013
- First submitted
- 30 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan: Correlation Between Radiotherapy Dose Distribution, Myocardial Perfusion, Cardiac Function, Serum Biomarkers and Clinical Prognosis.
- ClinicalTrials.gov ID
- NCT01913769
- Acronym / sponsor ID
- FEMH-IRB-102032-F
- Conditions
- Thoracic Neoplasms, Late Effect of Radiation
- Keywords
- post-RT, myocardial perfusion images
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 1 Aug 2013 (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.
Background:
Chemoradiation is an important treatment strategy of locally advanced inoperable or unresectable disease. Radiation dose is an independent predictor of a pathological response. In addition, chemotherapy has further impact on the aspect of outcome. Improvements in local treatment delivery are needed to facilitate dose escalation and to minimize toxicity. There have been sequential improvements in tumor localization, radiation planning and delivery over the years. Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to thoracic malignancies, and allows greater sparing of the heart from doses associated with increased complications. However, heart disease shows a wide spectrum of pathologies, and multiple risk factors related. The damage of the myocytes may lead to not only myocardial perfusion defects, but also in functional deterioration, or even in biomarkers.
Since the impact of radiation-induced heart injury in patients with thoracic malignancies (including esophageal cancer, lung cancer, et al) is poorly documented, we try to delineate of RT-related cardiac effects and clinical impacts.
Objective:
This study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies.
Methods:
The study plans to enroll thoracic cancer patients who will undergo local RT after complete staging. Patients will receive global risk scoring assessment (Framingham Risk Score, FRS), blood sampling for basic biochemistry, inflammatory biomarker, and myocardial perfusion image (MPI) at the time points of before and after RT. The results of MPI will be analyzed in qualitative visual interpretation of perfusion patterns, and functional quantitative data for cardiac functional parameters as well. The patients will be regular followed-up in CV OPD, following clinical judgement and guideline. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated.
Expected results:
We will obtain myocardial perfusion visual qualitative data in patients who received locoregional RT, respectively. These results will help in the understanding of pathophysiology, clinical management and follow-up of suspected RT-related heart disease.
Detailed description
The risk of RT-related heart disease is now well recognized but the underlying mechanisms of its initiation and progression, and the roles played by microvascular damage, fibrosis and atherosclerosis remain unclear. Studying RT-related heart disease have demonstrated that irradiation affects cardiac structure and microvascular function in a dose and time-dependent manner, with substantial damage after intermediate and high dose irradiation, and minor alterations after lower doses. Not only structural changes but also functional deterioration was noted. Studies disclosing that incidence of post 3D-RT perfusion defect is in approximately 40%, and the patients had volume-dependent perfusion defects within 2 years of RT.
To better evaluation of the RT-related heart disease, we plan to initiate a prospective study trail that takes advantage of recent technical advances in tomotherapy, and new Cadimium-Zinc-Telluride (CZT) cardiac camera.
- Estimated Case Number: 100 patients will be enrolled in the study.
- Patients with thoracic cancer will be transferred to CV OPD for initial cardiovascular risk factors assessment, before starting radiation therapy.
- Past history, family history, basic lab data and Framingham cardiovascular risk assessment will be applied. After approaching risk stratification, patients who were classified as intermediated to high risk need further work-up. Who needs to undergo myocardial perfusion study will be enrolled in the study before further RT course.
- All enrolled subjects provide basic demographic data and sign informed consents.
- Myocardial perfusion images with Tl-201 and CZT camera will be performed in nuclear medicine department of FEMH, completing baseline evaluation before RT.
- The patients received scheduled treatment plan, including RT.
- Follow-up CV OPD based on clinical decision and guideline: blood biochemistry and inflammation marker, CV risk scores. Further work-up would be indicated if functional status deterioration or aggravated symptoms.
- Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.
- Comparing the clinical follow-up data between groups, including global functional assessments, blood sampling data, myocardial perfusion scan, and quantitative cardiac functional parameters.
Blood sampling Peripheral blood will be drawn for measurements of blood glucose, lipid profile, and circulating biomarker of CRP. The genomic tests will not be involved in the study.
Myocardial perfusion study-for quantitative functional parameters, qualitative and quantitative myocardial perfusion scan. Patients referred for SPECT MPI for evaluation of CAD underwent a 1-day Tl-201 stress/rest MPI protocol, as daily practice in FEMH. Pharmacological stress was induced by standard dipyridomale infusion. Tl-201 of 2 mCi was injected after 7 min of induced stress. The software package Myovation for Alcyone (GE Healthcare), QGS and QPS were used for quantitative analysis off MPI polar maps using a 17-segment model for the left ventricle. Automated analysis of gated acquisitions from high-dose (rest) scans was performed to determine left ventricular ejection fraction (LVEF).
Integrated clinical information, follow-up and nuclear medicine cardiac scans performed in the time points of before \& after RT will be collected and analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation therapy | – | Radiation: Thallium-201 Myocardial Perfusion StudyThoracic cancer patient s/p scheduled RT will be arranged to undergo Thallium-201 Myocardial Perfusion Study. The scheduled RT will be arranged by clinical judgments of radiation-oncologists. All of the patients will receive myocardial SPECT before and after the scheduled RT. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with thoracic malignancy who scheduled further locoregional RT.
Key inclusion criteria (3 listed)
- Patients with thoracic malignancy who scheduled further locoregional RT.
- Aged 20-80 years old.
- Classified as intermediate to high future CV risk clinically.
Key exclusion criteria (3 listed)
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy.
- Any medical contraindication of stress cardiac SPECT.
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 |
|---|---|---|
| Thallium-201 Myocardial Perfusion StudyOne-day Tl-201 stress/rest MPI protocol with pharmacological stress, as daily practice will be applied. CZT camera with multipinhole collimator and stationary detectors scan heart simultaneously. A 10% symmetrical energy window at 140 keV was used. Electrocardiogram-gated scans will be applied. Perfusion images were reconstructed in standard axis and polar maps of the left ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers blinded to any information on patient identification. The software package Myovation for Alcyone, QGS and QPS were used for quantitative analysis of MPI polar maps. Automated analysis to determine ejection fraction. | Radiation | Radiation therapy |
Primary outcome
To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images
Time frame: July, 2014 (after 12 months of baseline study).
By literature reviewing, cardiovascular functional status in patients received helical tomography has not been fully investigated yet. And the post-therapeutic heart disease tends to show a wide spectrum of pathologies and multiple risk factors. We will monitor risk factors of underlying disease, family history, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineation of RT-related effects and clinical prognosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
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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.
Shan-Ying Wang, M.D. principal investigator
Far Eastern Memorial Hospital, Taiwan
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 Neoplasms and Late Effect of Radiation, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 1 Aug 2013. 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 Taiwan. 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?
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?
To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images (time frame: July, 2014 (after 12 months of baseline study).). 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 1 Aug 2013.