Clinical trial · Observational
The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes.
The Role of Myocardial SPECT in Evaluation of Irradiation-induced Changes With Myocardial Perfusion, Cardiac Function, Metabolism and Clinical Prognosis.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Female | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thallium-201 Myocardial Perfusion Study | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tomotherapy
- description
- 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.
- interventionNames
- Radiation: Thallium-201 Myocardial Perfusion Study
Primary outcomes (1)
- measure
- To investigate the correlation of post-RT cardiovascular effects with myocardial Tl-201 myocardial perfusion images
- timeFrame
- Dec, 2013 (after 12 months of baseline study).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion 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). * Aged 20-80 years old. Exclusion Criteria: * Pre-existing cardiac disease, such as prior myocardial infarction, documented CAD, congestive heart failure. * Pregnancy * Any medical contraindication of cardiac SPECT.
References
Publications (1)
- DERIVEDWang 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 37386034