Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous … (NCT06412419) | Clinical Trial Compass
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Multimodal Endoscopic Image Fusion for Assessing Infiltration in Superficial Esophageal Squamous Cell Carcinoma
China450 participantsStarted 2024-05-15
Plain-language summary
The objective of this project is to pioneer a novel protocol for the adjunctive screening of early-stage esophageal cancer and its precancerous lesions. The anticipated outcomes include simplifying the training process for users, shortening the duration of examinations, and achieving a more precise assessment of the extent of esophageal cancer invasion than what is currently possible with ultrasound technology. This research endeavors to harness the synergy of endoscopic ultrasound (EUS) and Magnifying endoscopy, augmented by the pattern recognition and correlation capabilities of artificial intelligence (AI), to detect early esophageal squamous cell carcinoma and its invasiveness, along with high-grade intraepithelial neoplasia. The overarching goal is to ascertain the potential and significance of this approach in the early detection of esophageal cancer.
The project's primary goals are to develop three distinct AI-assisted diagnostic systems:
An AI-driven electronic endoscopic diagnosis system designed to autonomously identify lesions.
An AI-based EUS diagnostic system capable of automatically delineating the affected areas.
A multimodal diagnostic framework that integrates electronic endoscopy with EUS to enhance diagnostic accuracy and efficiency.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients requiring magnifying endoscopy and endoscopic ultrasonography. Individuals of either sex, aged 18 years or older.
Exclusion Criteria:
Inability to complete esophageal electronic endoscopy. Absence of biopsy or surgery, resulting in unobtainable pathological results. Patients who have undergone endoscopic lesion destruction or piecemeal resection, preventing the acquisition of an en bloc resection sample.
Patients with significant endoscopic, imaging, or pathological evidence of advanced esophageal cancer.
Patients presenting with marked esophageal stenosis or dilatation. Individuals with a history of other malignancies. Patients who have received neoadjuvant radiotherapy. Patients who declined to participate in the study and did not provide informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performance of models to diagnose low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and superficial esophageal squamous carcinoma