A Screening Program to Improve the Early Detection of Sporadic Pancreatic Cancer in Individuals With a High-Risk of Developing Pancreatic Cancer (AI-PACED)

MC250406 Feasibility Study: Automated Risk Stratification, Serial AI-Augmented Imaging, and Biobanking for Early Detection of Sporadic Pancreatic Cancer (AI-PACED)

This clinical trial studies a new screening program to improve the early detection of sporadic pancreatic cancer in individuals with a high risk of developing pancreatic cancer. Pancreatic cancer remains one of the deadliest solid tumors, characterized by a long phase without symptoms followed by rapid progression once clinically evident. Despite advancements in treatment, the survival rate for pancreatic cancer remains low. Research has helped to identify a subset of individuals with a markedly high short-term risk for developing pancreatic cancer, which includes adults aged 50 and older with glycemically-defined new-onset diabetes and an Enriching New-Onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3. However, current practice guidelines do not provide clear pathways for surveillance or early detection. The screening program in this trial combines repeated contrast-enhanced computed tomography (CT) scans using artificial intelligence (AI) and blood draws. Contrast-enhanced CT is an imaging technique which creates a series of detailed pictures of areas inside the body; the pictures are created by a computer linked to an x-ray machine and a contrast agent is used to enhance the images. The images are then reviewed using AI, which may make it easier to spot cancer earlier on the CT scans than with the human eye. Studying samples of blood in the laboratory from high-risk individuals may help doctors understand more about why they may develop pancreatic cancer. This may be an effective way to screen high-risk individuals and improve the early detection of sporadic pancreatic cancer.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Ductal Adenocarcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Procedure: Computed Tomography with Contrast; Other: Electronic Health Record Review

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Alyssa Johnson; Phone Number: 507-422-9721

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Alyssa Johnson; Phone Number: 507-422-9721
      • Contact: Ashley Braen; Phone Number: 507-266-0544
      • Principal Investigator: Ajit H. Goenka, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 50 and ≤ 85 years
• Glycemically-defined new-onset diabetes (gNOD) with onset ≤ 180 days preceding enrollment
• Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score ≥ 3, based on validated risk stratification models
• Provide written or remote informed consent

Exclusion Criteria:

• Prior diagnosis of pancreatic ductal adenocarcinoma (PDA)
• Known hereditary cancer syndromes (e.g., BRCA1/2, Lynch syndrome, Peutz-Jeghers)
• Prior history of pancreatic surgery
• Pancreatic cyst surveillance at time of registration
• Contraindications to contrast-enhanced CT imaging per standard clinical practice at time of registration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A1 (CT, blood, EMR surveillance); Patients undergo contrast-enhanced abdominal CT and blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Procedure: Computed Tomography with Contrast; Undergo contrast-enhanced abdominal CT; Other Names: Contrast Enhanced Computed Tomography; CONTRAST ENHANCED CT SCAN; Contrast-enhanced Computed Tomography; CT Scan With Contrast; CT with Contrast; Other: Electronic Health Record Review; Undergo electronic medical record (EMR) surveillance
Experimental: Group A2 (blood, EMR surveillance); Patients undergo blood sample collection at baseline, 6 months, and 12 months in the absence of unacceptable toxicity. Patients also undergo EMR surveillance for PDA diagnosis for up to 36 months.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Electronic Health Record Review; Undergo electronic medical record (EMR) surveillance
Active Comparator: Group B (EMR surveillance); Patients undergo EMR surveillance for PDA diagnosis for up to 36 months.	Other: Electronic Health Record Review; Undergo electronic medical record (EMR) surveillance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment yield (Feasibility)	Will assess the feasibility of protocol implementation as defined by recruitment yield (% of flagged high-risk individuals who consent). Descriptive statistics will be used to summarize feasibility endpoints.	Up to 3 years
Imaging adherence rates (Feasibility)	Will assess the feasibility of protocol implementation as defined by imaging adherence rates (% completing 3 scheduled computed tomography scans). Descriptive statistics will be used to summarize feasibility endpoints.	Up to 3 years
Blood collection success rates (Feasibility)	Will assess the feasibility of protocol implementation as defined by blood collection success rates (% completing 3 scheduled blood collections). Descriptive statistics will be used to summarize feasibility endpoints.	Up to 3 years
Completeness of electronic medical record (EMR)-based follow-up (Feasibility)	Will assess the feasibility of protocol implementation as defined by completeness of EMR-based follow-up (% of participants with outcome ascertainment). Descriptive statistics will be used to summarize feasibility endpoints.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from glycemically-defined new-onset diabetes (gNOD) onset to pancreatic ductal adenocarcinoma (PDA) diagnosis	Time to PDA diagnosis will be compared between cohorts.	Up to 3 years
Proportion of PDAs diagnosed at stage 0/I	Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).	Up to 3 years
Rate and type of incidental findings requiring downstream evaluation	Comparisons between cohorts will employ log-rank tests. Will also employ Cox proportional hazards models adjusted for baseline covariates (exploratory only).	Up to 3 years
Artificial intelligence (AI)-detected imaging signatures and standard radiologist interpretations	Will complete discordance analysis between AI-detected imaging signatures and standard radiologist interpretations, including rates of earlier detection and false positives.	Up to 3 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Ajit H. Goenka, MD, Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2026
• Primary Completion (Estimated): March 24, 2029
• Study Completion (Estimated): March 24, 2029

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Diagnostic Uses of Chemicals; Specimen Handling; Contrast Media
• Other Study ID Numbers: MC250406 (Other Identifier: Mayo Clinic); NCI-2025-09279 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 25-009433 (Other Identifier: Mayo Clinic Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No