跳至主要内容
临床试验/CTRI/2025/10/096027
CTRI/2025/10/096027尚未招募不适用

AI-Driven prediction of Occult Peritoneal Metastases using Pre-operative Clinical and CT data in Gastrointestinal and Gynaecological cancers.

ICMRDHR1 个研究点 分布在 1 个国家目标入组 765 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
765
试验地点
1
主要终点
Prediction of occult peritoneal metastases from gastric and ovarian cancer using Artificial intelligence/deep learning based model on CT scan.

研究概览

简要总结

Introduction:

According to GLOBOCAN 2022, in the year 2022, there were 968,000 new cases of gastric cancer and close to 660,000 deaths, ranking gastric cancer as fifth in terms of both incidence and mortality worldwide, while ovarian carcinoma had 324,398 new cases and 206,839 deaths worldwide, making it the 8th most common cancer with respect to incidence and mortality among women. In India, 10056 new cases of gastric cancer were registered between 2012 and 2016, and thus it ranks second amongst the gastrointestinal cancers.  The presence of occult peritoneal metastases (PM) is currently difficult to diagnose in pre-operative radiological images, and many patients are found to have these metastases as a surprise finding during their elective surgery. This, thus, often results in abandoning a curative surgery for several reasons, such as the absence of adequate instruments or machinery for hyperthermic intra-peritoneal chemotherapy (HIPEC), or the patient might not be clinically fit for the extensive procedure, which would typically last for a minimum of 10 hours. Also, it adds to undue stress on the patient and the caretakers, especially since the patient is now termed as “metastatic” or “Stage IV” in layman’s terms. Moreover, if the presence of PM were to be detected preoperatively, the patient could have been adequately prepared for a successful cytoreductive surgery (CRS). This would then drastically improve the survival outcomes.

With the advent of artificial intelligence (AI) and deep learning (DL) in healthcare, especially in radiology, the accuracy of preoperative diagnosis has now improved in breast and brain tumors. The use of AI and DL in gastrointestinal tumors and gynecological malignancies is still in its infancy.  The DL approach is a novel method for image-based determination of complex relationships and has exhibited sophisticated performance for small feature detection and characterization. However, there is still a lack of integration of these radiological images with the intraoperative images. By having such a collaborative picture, the surgical outcomes can be improved.

Methodology:

A cross-sectional analysis of patients admitted with gastric adenocarcinoma and serous ovarian carcinoma and detected to have occult PM on staging laparoscopy or laparotomy will be performed. The patient’s clinical data and pre-operative CT imaging performed within four weeks of surgery will be obtained. The CT images will be segmentated manually for the primary and the peritoneum. The data will then be split randomly into training and test datasets using a 4:1 ratio. Using these CT images, radiomic signatures will be extracted using DL methods, and a radiomic feature set will be developed from the training cohort. The AI and DL model thus developed will be validated on the internal and external testing cohorts. Similarly, a clinical model will be developed and will be integrated with the AI/DL based CT model to produce a comprehensive model.

Conclusion:

The AI/DL model thus developed will be able to predict the occult peritoneal metastases on pre-operative imaging, avoiding unnecessary surgeries and/or providing personalised surgical planning.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Locally advanced adenocarcinoma stomach patients who have undergone staging laparoscopy (SL) or laparotomy and have been found to have occult peritoneal metastases.
  • Locally advanced serous ovarian carcinoma patients who have undergone laparotomy and are found to have occult peritoneal metastases.
  • All the above patients have had a pre-operative CT scan done in the hospital within 4 weeks prior to the surgery.

排除标准

  • Patients undergoing surgery for gastric malignancy other than adenocarcinoma, such as neuroendocrine tumors, gastrointestinal stromal tumors.
  • Patients undergoing surgery for ovarian malignancy other than serous ovarian carcinoma, such as benign pathology, early serous carcinoma, mucinous carcinoma, or clear cell carcinoma.
  • Patients who do not have pre-operative CT imaging available for analysis, or the CT is not of diagnostic quality.
  • Patients whose CT was done more than 1 month prior to the surgery.
  • Patients whose intraoperative notes do not contain any details about peritoneal findings.

结局指标

主要结局

Prediction of occult peritoneal metastases from gastric and ovarian cancer using Artificial intelligence/deep learning based model on CT scan.

时间窗: 4 years

次要结局

  • Prediction of occult peritoneal metastases from gastric and ovarian cancer using combined clinical and deep learning CT based model.(4.5 years)

研究者

发起方
ICMRDHR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Dr Preethi S Shetty

Kasturba Medical College, Manipal

研究点 (1)

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