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临床试验/NCT07416825
NCT07416825已完成不适用

Inter-observer Delination Variation in Esophageal Cancer Radiotherapy by Use of Magnetic Resonance

Institute of Oncology Ljubljana1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
23
试验地点
1
主要终点
Volumetric Conformity Index (VCI) Compared With Reference Contour

研究概览

简要总结

Esophageal cancer radiotherapy requires accurate delineation of the gross tumor volume (GTV) to ensure adequate tumor coverage and to minimize radiation dose to surrounding organs at risk. Computed tomography (CT) is routinely used for target delineation, while positron emission tomography-computed tomography (PET/CT) may provide additional functional information. However, uncertainty in tumor boundaries and inter-observer variation remain clinically relevant issues.

Magnetic resonance imaging (MRI) provides improved soft tissue contrast and diffusion-weighted imaging (DWI) information, which may improve visualization of esophageal tumors. This study evaluates whether MRI-based imaging, alone or fused with CT or PET/CT, reduces inter-observer variation in GTV delineation compared with standard CT and PET/CT-based delineation.

A total of 21 patients with locally advanced esophageal cancer undergoing standard radiotherapy preparation will undergo MRI simulation in addition to routine CT and PET/CT simulation. Five experienced radiation oncologists will independently delineate the primary tumor GTV on CT, MRI, PET/CT, CT-MRI fusion, and PET/CT-MRI fusion datasets. Inter-observer variation will be assessed using conformity indices and spatial analysis tools.

详细描述

Accurate target volume delineation is essential in radiotherapy for esophageal cancer, as contouring uncertainty may lead to geographic miss or increased dose to organs at risk. CT imaging is the standard modality used for radiotherapy planning; however, CT has limited soft tissue contrast, which can make delineation of the proximal and distal tumor extent challenging. PET/CT may assist in staging and may provide functional tumor information, but its value for precise target delineation remains uncertain.

MRI has recently gained importance in radiotherapy planning due to improved anatomical soft tissue visualization and functional imaging such as diffusion-weighted imaging (DWI). Technical advances have improved thoracic MRI feasibility, and MRI may allow improved identification of tumor borders in the esophagus. The clinical role of MRI in reducing inter-observer delineation variability in esophageal cancer radiotherapy planning is not yet well established.

This prospective study compares inter-observer variation in gross tumor volume (GTV) delineation across different imaging modalities used in radiotherapy preparation. Patients with locally advanced esophageal cancer will undergo standard PET/CT simulation according to institutional protocol and additional MRI simulation performed with identical immobilization. MRI will include T2-weighted sequences and DWI sequences without intravenous contrast.

Five experienced radiation oncologists will independently delineate the primary tumor GTV on anonymized datasets using the Eclipse treatment planning system. Contouring will be performed separately on the following image sets: CT, MRI, PET/CT, CT fused with MRI, and PET/CT fused with MRI. Pathologic lymph nodes will not be included in the GTV. A washout period of at least 14 days will be maintained between contouring sessions for the same patient on different imaging modalities.

Inter-observer variation will be assessed using the generalized conformity index (CIgen). Additionally, reference contours will be generated using the STAPLE algorithm. The Contour Analysis Tool (CAT) will be used to calculate planar and volumetric conformity indices (PCI and VCI) and to perform spatial analysis based on inter-delineation distance measurements. Contouring time, image quality, and perceived delineation difficulty will also be recorded by observers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Imaging datasets and observer identities are anonymized. Delineations are performed independently.

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

  • Age ≥18 years
  • Locally advanced esophageal cancer (T1b-4b, N0-N+, M0)
  • Siewert type I or II for distal esophageal tumors
  • Planned preoperative or definitive chemoradiotherapy
  • Written informed consent for participation in the study
  • No contraindications for MRI

排除标准

  • Implanted metallic objects with magnetic properties or electromagnetic devices without MRI compatibility confirmation
  • Physical or psychological conditions preventing informed consent

研究组 & 干预措施

CT

Active Comparator

Standard planning CT for GTV delineation.

干预措施: Computed Tomography (CT) (Diagnostic Test)

MRI

Experimental

MRI simulation for GTV delineation.

干预措施: Magnetic Resonance Imaging (MRI) (Diagnostic Test)

PET/CT

Active Comparator

PET/CT simulation for GTV delineation.

干预措施: Positron Emission Tomography/Computed Tomography (PET/CT) (Diagnostic Test)

CT + MRI Fusion

Experimental

CT images fused with MRI for GTV delineation.

干预措施: CT-MRI Image Fusion (Diagnostic Test)

PET/CT + MRI Fusion

Experimental

PET/CT images fused with MRI for GTV delineation.

干预措施: PET/CT-MRI Image Fusion (Diagnostic Test)

结局指标

主要结局

Volumetric Conformity Index (VCI) Compared With Reference Contour

时间窗: Up to 14 days after completion of contouring for each imaging dataset

Volumetric conformity index (VCI) will be calculated using the Contour Analysis Tool (CAT) by comparing each observer's gross tumor volume (GTV) contour to a reference contour generated using the STAPLE algorithm. VCI is defined as the ratio of intersection volume to union volume and ranges from 0 to 1. The outcome will be reported as mean VCI for each imaging dataset.

Inter-observer Variability in GTV Delineation (Generalized Conformity Index, CIgen)

时间窗: Up to 14 days after completion of contouring for each imaging dataset

Inter-observer agreement in gross tumor volume (GTV) delineation will be assessed using the generalized conformity index (CIgen) calculated using the Contour Analysis Tool (CAT). CIgen is defined as the ratio of the sum of pairwise intersections to the sum of pairwise unions of all observers' contours and ranges from 0 to 1. The outcome will be reported as CIgen for each imaging dataset.

Image Quality Rating (5-point Likert Scale)

时间窗: During contouring sessions (up to 14 days per imaging dataset)

Observers will rate the image quality of each imaging dataset (CT, MRI, PET/CT, CT-MRI fusion, PET/CT-MRI fusion) using a 5-point Likert scale (1 = very poor, 5 = excellent). The outcome will be reported as mean image quality score.

次要结局

  • Planar Conformity Index (PCI) Compared With Reference Contour(Up to 14 days after completion of contouring for each imaging dataset)
  • Spatial Inter-delineation Distance (IDD) Between Observer Contours and Reference Contour(Up to 14 days after completion of contouring for each imaging dataset)
  • Contouring Time(During contouring sessions (up to 14 days per imaging dataset))
  • Perceived Difficulty of Delineation (5-point Likert Scale)(During contouring sessions (up to 14 days per imaging dataset))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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