The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes.
1 other identifier
observational
60
1 country
1
Brief Summary
Helical tomotherapy nowadays provides the most precise data on radiotherapy (RT) dose delivered to each region of the heart in left-sided breast cancer therapy, which 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. In this study, we will monitor cardiovascular (CV) risk factors, metabolism, biomarkers, myocardial perfusion defect patterns, and cardiac functional parameters, in order to delineate of RT-related effects and clinical impacts. Objective: The pilot study aims to investigate the correlation of post-tomotherapy cardiovascular effects with myocardial perfusion and cardiac functional studies. Methods: The study plans to enroll female breast cancer patients who will undergo local RT after their surgery. 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. The association between baseline and follow-up MPI, biomarker and clinical presentation will be further investigated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 27, 2012
CompletedFirst Posted
Study publicly available on registry
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedMay 8, 2014
July 1, 2013
2 years
December 27, 2012
May 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Dec, 2013 (after 12 months of baseline study).
Study Arms (1)
Tomotherapy
Breast cancer female 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. Comparing the clinical follow-up data between different groups (left-sided s/p tomography, left-sided s/p conventional RT, and right-sided RT), respectively.
Interventions
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
Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
You may qualify if:
- Female patients with breast cancer who scheduled further regional RT. Groups of left-sided breast cancer (tomotherapy, conventional RT), and right breast cancer (conventional RT).
- Aged 20-80 years old.
You may not qualify if:
- Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure.
- Pregnancy
- Any medical contraindication of cardiac SPECT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Far Eastern Memorial Hospital
New Taipei City, 220, Taiwan
Related Publications (1)
Wang SY, Lin KH, Wu YW, Yu CW, Yang SY, Shueng PW, Hsu CX, Wu TH. Evaluation of the cardiac subvolume dose and myocardial perfusion in left breast cancer patients with postoperative radiotherapy: a prospective study. Sci Rep. 2023 Jun 29;13(1):10578. doi: 10.1038/s41598-023-37546-7.
PMID: 37386034DERIVED
Biospecimen
Venous blood sampling
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shan-Ying Wang, M.D.
Far Eastern Memorial Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2012
First Posted
January 1, 2013
Study Start
December 1, 2012
Primary Completion
December 1, 2014
Study Completion
November 1, 2015
Last Updated
May 8, 2014
Record last verified: 2013-07