Development of the initial prototype of a pill sensor to detect colonic polyps and early bowel cancer

点击翻译按钮获取中文摘要

Bowel cancer causes nearly a million deaths per annum, and more than half of cases are fatal. Although early cancer detection can significantly improve patients' outcomes, more than half of bowel cancer cases in the UK are diagnosed at a late stage. Detection of bowel cancer and pre-cancerous polyps is currently predominantly performed by either visual inspection of the colonic mucosa during endoscopy (colonoscopy), which is an invasive procedure, or by cross-sectional imaging, which is less reliable for small-sized lesions that are not easily visualised. If such polyps are not detected and removed at an early stage, there is a chance that they may become cancerous. Recently, direct visualisation of the colon using colonic capsule endoscopy has been introduced, but uptake by clinicians has been limited due to concerns about missed lesions with this modality, with potentially catastrophic outcomes for patients.Leveraging our pioneering work in the field of controllable capsule technologies, our team has developed a novel, untethered, vibrational, AI-assisted, ingestible pill sensor, with the aim of detecting small colonic lesions by a new modality (DOI:10.1109/LRA.2023.3251853). After swallowing this pill-based device, it will pass through the patient's gastrointestinal (GI) tract through gut motility and peristalsis. Dynamic signals from the pill in contact with in-situ bowel lesions can be acquired and analysed for features that are indicative of biomechanical changes in the tissues, to infer benign or malignant lesions. Design innovations include the vibrational mechanism for encouraging pill-lesion interactions, a portable platform for interaction signal acquisition, and disposable components: after each procedure, the pill's outer shell is discarded, whilst the main components are reclaimed without reprocessing, dramatically reducing the cost. The platform is small and lightweight, with significantly reduced capital costs compared to standard colonoscopy. Early experiments in our laboratory demonstrate an average accuracy of 96.5% in successful detection of simulated colonic lesions (DOI:10.1109/LRA.2023.3251853). This novel pill sensor is therefore planned to facilitate an alternative to both colonoscopy and current colonic capsule endoscopy.This project aims to develop an initial prototype of this pill sensor in fusion with artificial intelligence to aid the detection of hard-to-visualise bowel lesions. This novel diagnostic tool will be developed, optimised, and tested in this 18-month research programme. By the end of this project, we will deliver a proof-of-concept prototype at TRL 3 that is ready for in-vivo testing. To this end, we will pursue this aim by (1) integrating all the required components, including on-board vibrator and sensor (e.g., accelerometer), data storage, and power supply, (2) optimising the controllability and integrity of the pill, (3) using the dynamic signals acquired by the on-board sensor to perform autonomous detection of lesions, (4) benchmarking the proposed technology with standard colonic capsule endoscopy in multiple validation scenarios in a laboratory setting, (5) optimising the initial prototype for clinical use based on clinical feedback.In the long term, this work will initiate a new, minimally invasive, investigative modality for patients and clinicians that is comfortable, safe, reliable, accurate and cost-effective in the detection of pre-cancerous and early cancerous lesions.