跳至主要内容
临床试验/NCT07537491
NCT07537491招募中不适用

Staged Unimodal-to-Multimodal AI Analysis of Histopathology, CT/MRI, and Multiplex Tissue Imaging for Perioperative Risk Prediction in Colorectal Cancer (KIA-Korekt)

Rene Mantke1 个研究点 分布在 1 个国家目标入组 910 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
910
试验地点
1
主要终点
Prediction accuracy of perioperative complications

研究概览

简要总结

Perioperative complications following surgery for colorectal cancer (CRC) represent a major cause of postoperative morbidity and mortality. Existing risk stratification tools lack the precision to capture the complex biological and morphological factors that determine individual patient vulnerability. Artificial intelligence (AI)-based analysis of medical imaging data offers a promising approach to improve preoperative risk prediction.

The KIA-Korekt study investigates whether perioperative complications in CRC patients can be predicted using multimodal AI-based image analysis. Three complementary imaging modalities are integrated: digital histopathology (haematoxylin-eosin whole-slide images, H&E-WSIs), preoperative CT and MRI radiomics, and multiplex tissue imaging (mTI) including multiplex immunohistochemistry (mIHC) and imaging mass cytometry (IMC).

The study includes a retrospective cohort of approximately 750 CRC patients treated between 2011 and 2021, and a prospective validation cohort of approximately 210 patients recruited from 2026 to 2028. Deep learning and radiomic feature extraction pipelines are applied to all modalities individually and in multimodal combination. Predicted outcomes include anastomotic leakage, wound infection, sepsis, ICU admission, and in-hospital mortality within 30 days of surgery.

The study is conducted at the University Hospital Brandenburg, Brandenburg Medical School Theodor Fontane, in collaboration with the Department of Computational Pathology, TU Dresden.

详细描述

Colorectal cancer (CRC) is one of the most prevalent malignancies worldwide. Despite advances in surgical technique and perioperative care, short-term postoperative complications remain frequent and substantially impact patient quality of life, healthcare costs, and long-term prognosis. These complications include anastomotic leakage, wound infection, sepsis, thromboembolic events, and in-hospital mortality. Existing clinical risk scores (ASA, POSSUM) provide only limited individualised risk stratification and do not incorporate imaging-derived biological markers.

The KIA-Korekt study addresses this gap by developing and validating AI-based predictive models for perioperative complications in CRC, integrating three complementary imaging modalities:

Digital histopathology: Haematoxylin-eosin stained whole-slide images (H&E-WSIs) from surgical resection specimens and preoperative biopsies are analysed using attention-based multiple instance learning (MIL) and convolutional neural networks (CNNs), building on established pipelines from the Department of Computational Pathology, TU Dresden (AG Kather).

Radiology: Preoperative CT and MRI images are processed using automated segmentation (TotalSegmentator, nnU-Net) and radiomic feature extraction (PyRadiomics). Features are derived from the primary tumour, psoas muscle (sarcopenia), and visceral/subcutaneous fat compartments. A dedicated multi-metric quality control pipeline ensures stable imaging data representations across scanners and acquisition protocols.

Multiplex tissue imaging (mTI): Multiplex immunohistochemistry with multispectral imaging (mIHC-MSI) and imaging mass cytometry (IMC) are applied to formalin-fixed paraffin-embedded tumour tissue to characterise immune and stromal cell populations, marker expression intensities, and spatial distribution patterns within the tumour microenvironment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Adult patients (≥18 years)
  • Histologically confirmed colorectal adenocarcinoma
  • Undergoing surgical resection (curative or palliative intent)
  • Availability of H&E-stained whole-slide images (WSIs) from the primary tumour

排除标准

  • Patients not undergoing surgical treatment
  • Missing H&E-stained tissue slides of the primary tumour
  • Histopathological material of insufficient quality for analysis

研究组 & 干预措施

Group 1: Retrospective Training Cohort

Patients with colorectal cancer treated between 2011-2021 with available imaging and histopathology data.

Prospective Cohort

Patients with colorectal cancer enrolled prospectively between 2026-2028.

结局指标

主要结局

Prediction accuracy of perioperative complications

时间窗: 30 days postoperative

Occurrence of postoperative complications including anastomotic leakage, sepsis, ICU admission, and in-hospital mortality. Outcomes are defined based on clinical documentation and assessed as binary variables (yes/no).

次要结局

未报告次要终点

研究者

发起方
Rene Mantke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rene Mantke

Univ.-Prof. Dr. med.

Medizinische Hochschule Brandenburg Theodor Fontane

研究点 (1)

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