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临床试验/NCT06938074
NCT06938074尚未招募不适用

Imaging and Treatment Planning for Cardiac Radioablation

Stewart Gaede1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
15
试验地点
1
主要终点
Agreement among cardiologists for target regions, assessed by an inter- and intra-observer variability study using similarity metrics such as the Dice coefficient and Hausdorff distance.

研究概览

简要总结

Cardiac radioablation is a new treatment for ventricular tachycardia (VT), which uses beams of radiation to treat heart scar that causes VT. To identify the scar areas, magnetic resonance imaging (MRI) and computed tomography (CT) imaging are often used. These are both types of medical imaging that allow clinicians to examine scar area without having to do invasive surgery.

Researchers have developed new heart imaging protocols using both MRI and CT. Their MRI protocol method can now spot both dense and scattered scar tissue. The CT protocol combines multiple different types of scans into a single appointment and uses a special scanner that captures the motion of the heart. For this study, patients will undergo CT and MRI imaging according to these new imaging protocols.

With this study, researchers aim to show that these new imaging protocols can be undergone by patients with ventricular tachycardia and can be used to identify scar. Researchers will also use these scans to make radiation treatment plans to identify which types of treatment can be delivered safely to patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ischemic cardiomyopathy with monomorphic VT
  • Referred by cardiologists
  • 18 years of age or older

排除标准

  • • Polymorphic ventricular tachycardia
  • Ventricular fibrillation
  • Pregnant or breastfeeding or planning to become pregnant or breastfeed during the study
  • Estimated glomerular filtration rate ≤ 30 mL/min/1.73m2
  • Previous allergic reaction to CT contrast agent Note that participants with contraindications for MRI can still be enrolled in this study but will not undergo MRI parts of this protocol.

结局指标

主要结局

Agreement among cardiologists for target regions, assessed by an inter- and intra-observer variability study using similarity metrics such as the Dice coefficient and Hausdorff distance.

时间窗: 6 months after conclusion of study

Imaging protocols will be delivered to participants. Targets will be delineated by experts. Agreement between experts will be assessed..

Adherence of treatment plans to dose constraints and deliverability of treatment plans.

时间窗: 6 months after conclusion of study

Treatment plans will be created using various motion management and radiation treatment delivery strategies. Adherence of treatment plans to dose constraints will be assessed by comparing treatment plans to institutional dose constraints. Beam deliverability will be assessed by delivering the treatment plan to a static phantom and comparing the deposited dose to the expected dose. Treatment deliverability, as it relates to motion management, will be assessed by delivering the treatment plan to a moving phantom and comparing the deposited dose to the expected dose.

次要结局

  • Agreement between CT/MRI areas of interest (scar), assessed using similarity metrics such as the Dice coefficient and Hausdorff distance.(6 months after conclusion of study)

研究者

发起方
Stewart Gaede
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Stewart Gaede

Chief Medical Physicist

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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