Monitoring Radiobiological Effects in Thoracic Malignancy by Using Myocardial Perfusion Scan
NCT ID: NCT01913769
Last Updated: 2013-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
100 participants
OBSERVATIONAL
2013-07-31
2016-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
1. Patients with thoracic cancer will be transferred to CV OPD for initial cardiovascular risk factors assessment, before starting radiation therapy.
2. 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.
3. All enrolled subjects provide basic demographic data and sign informed consents.
4. Myocardial perfusion images with Tl-201 and CZT camera will be performed in nuclear medicine department of FEMH, completing baseline evaluation before RT.
5. The patients received scheduled treatment plan, including RT.
6. 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.
7. Post-therapeutic myocardial perfusion study 12 months after first CV OPD visit.
8. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Thallium-201 Myocardial Perfusion Study
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Thallium-201 Myocardial Perfusion Study
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Aged 20-80 years old.
* Classified as intermediate to high future CV risk clinically.
Exclusion Criteria
* Pregnancy.
* Any medical contraindication of stress cardiac SPECT.
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Far Eastern Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shan-Ying Wang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Far Eastern Memorial Hospital, Taiwan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Far Eastern Memorial Hospital
New Taipei City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FEMH-IRB-102032-F
Identifier Type: -
Identifier Source: org_study_id