Screening Program for Early Detection of Pancreatic Cancer

(AI-PACED Trial)

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

AH

Ajit H. Goenka, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults aged 50-85 with a high risk of pancreatic cancer, indicated by new-onset diabetes and an ENDPAC score ≥ 3. Participants must consent to the study's procedures.

Inclusion Criteria

I have given my consent in writing or remotely for participation.
My ENDPAC score for pancreatic cancer risk is 3 or higher.
I am between 50 and 85 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline contrast-enhanced abdominal CT and blood sample collection

1 week
1 visit (in-person)

Surveillance

Participants undergo contrast-enhanced CT and blood sample collection at 6 and 12 months, with EMR surveillance for PDA diagnosis

12 months
2 visits (in-person)

Extended Follow-up

Participants continue EMR surveillance for PDA diagnosis

24 months

Follow-up

Participants are monitored for safety and effectiveness after the main surveillance period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Biospecimen Collection
  • Computed Tomography with Contrast

Trial Overview

The trial tests a screening program using AI-enhanced CT scans and blood tests to detect sporadic pancreatic cancer early in high-risk individuals.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Group I: Group A2 (blood, EMR surveillance)Experimental Treatment2 Interventions
Group II: Group A1 (CT, blood, EMR surveillance)Experimental Treatment3 Interventions
Group III: Group B (EMR surveillance)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+