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临床试验/CTRI/2025/11/097943
CTRI/2025/11/097943尚未招募不适用

Smart Surgical Margins: An Artificial Intelligence Powered RealTime Cancer Residual Detection Using Fluorescence Imaging System: A Cross-Sectional Study at a Tertiary Care Hospital in Mandya

Mandya Institute of Medical Science MIMS1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5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
120
试验地点
1

研究概览

简要总结

This is a prospective observational cross sectional diagnostic accuracy study that evaluates an ex vivo near infrared indocyanine green fluorescence imaging system with computer vision and machine learning for assessment of surgical margins on excised breast and colorectal cancer specimens. Fresh inked specimens are imaged in a light tight enclosure under 785 nm excitation with about 830 nm emission capture. The index test produces margin heatmaps and tumour to background ratio metrics on an NVIDIA Jetson platform. The reference standard is histopathology H and E of targeted and control slices from each margin face. Primary outcomes are sensitivity specificity and area under the ROC curve for face level classification against histopathology. Secondary outcomes include time to result per slice diagnostic metrics inter observer agreement and concordance of AI hotspots with histologic margin distance. Adults of eighteen years and above undergoing curative intent surgery are included. Metastatic disease and specimens unsuitable for imaging are excluded. The goal is to deliver same day triage that guides pathology slicing reduces delays and builds a labelled dataset for future in vivo translation.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18 years and above Primary breast cancer or colorectal cancer scheduled for surgery with curative intent R0 goal Fresh excised specimen available immediately for ex vivo imaging in the laboratory Indocyanine green used as per routine care or eligible for topical ex vivo protocol as approved by ethics Specimen orientation recorded and margins inked before imaging Time from excision to imaging within four hours Written informed consent obtained or ethics approved waiver for discarded tissue.

排除标准

  • Metastatic disease or palliative cytoreductive resections Known hypersensitivity to indocyanine green or iodides when systemic indocyanine green is used Pregnancy or lactation when systemic indocyanine green is not permitted by local policy Specimen unsuitable for imaging due to heavy cautery fragmentation inadequate fluorescence or gross contamination Time to imaging more than four hours after excision Uncontrolled diabetes as judged by the treating team if you wish to retain this from your proposal Any serious medical or logistical condition that prevents safe handling imaging or timely processing of the specimen Any exclusion mandated by the Institutional Ethics Committee.

研究者

发起方
Mandya Institute of Medical Science MIMS
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr N Lingaraju

Mandya Institute of Medical Science

研究点 (1)

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