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EUS-Based Artificial Intelligence to Predict Outcomes in Pancreatic Cancer

NCT07803770 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 700

Last updated 2026-09-04

No results posted yet for this study

Summary

The EUS-AI-R study is an observational, single-center, two-phase (retrospective-prospective) study designed to develop and validate artificial intelligence (AI) models for predicting chemotherapy response and oncological outcomes in patients with pancreatic ductal adenocarcinoma (PDAC).

Patients who underwent endoscopic ultrasound (EUS) with tissue acquisition (EUS-FNA/FNB) for suspected pancreatic lesions at IRCCS San Raffaele Hospital between January 1st, 2019 and January 2026 will be retrospectively included. All patients have a histologically confirmed diagnosis of PDAC and a minimum follow-up of six months. These data derive from an IRB-approved institutional study (BIOPANCREAS; NCT06552078).

Retrospective multimodal data, including EUS imaging (B-mode, elastography, contrast-enhanced EUS), clinical and laboratory variables, CT/MRI imaging, digital pathology, and molecular data when available, will be used to develop and internally validate multiple AI models.

In the prospective phase, the best-performing AI model will be applied to an independent cohort of patients undergoing EUS at the same institution to evaluate feasibility, calibration, and real-world performance.

No additional procedures beyond standard clinical practice will be performed.

Conditions

  • Pancreatic Neoplasms
  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Artificial Intelligence (AI)
  • Endoscopic Ultrasound (EUS)
  • Radiomics

Interventions

OTHER

Endoscopic ultrasound (EUS), with or without tissue acquisition (EUS-FNA/FNB), performed according to standard clinical practice. No study-specific intervention is introduced.

Endoscopic ultrasound (EUS), with or without tissue acquisition (EUS-FNA/FNB), performed according to standard clinical practice. No study-specific intervention is introduced.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07803770 on ClinicalTrials.gov