Recruiting

Pancreatic Cancer Screening

Sponsor:

Nuvance Health

Code:

NCT03250078

Conditions

Pancreatic Neoplasms

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

MRI/MRCP

Study Details

Brief summary:

The main goal of this study is to screen and detect pancreatic cancer and precursor lesions in individuals with a strong family history or genetic predisposition to pancreatic cancer. Magnetic Resonance Imaging and Magnetic cholangiopancreatography (MRI/MRCP) will be utilized to screen for early stage pancreatic cancer or precursor lesions. Participants will be asked to donate a blood sample at specific intervals for the creation of a bio-bank necessary for the development of a blood based screening test for Pancreatic Cancer.

Conditions

Pancreatic Neoplasms

Study ID

NCT03250078

Start date

Nov, 2016

Status verified date

Apr, 2026

Completion date

Nov, 2030

Anticipated

Primary completion date

Nov, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Registration-Inclusion Criteria for FAMILIAL PANCREATIC CANCER (FPC) and those with a BRCA1, BRCA2, LYNCH SYNDROME, ATM, PALB2, CDKN2A, or related gene mutation (one of the following is required for questions 1-3)

1. For FPC: The individual has at least 2 first-degree relatives (FDR) with PC.
2. For FPC: The individual has at least 3 first-, second-, or third-degree relatives with PC with at least 1 PC in a FDR.
3. The individual is a known mutation carrier of BRCA1, BRCA2, MLH1, MSH2, MSH6, or PMS2, ATM, PALB2, CDKN2A, or similar high-risk gene mutation and has at least 1 first- or second-degree relative with PC.
4. The individual is at least 50 years old or 10 years younger than the youngest relative with PC.
5. ECOG Performance Status of 0-1.
6. No known contraindications to MRI examination or gadolinium contrast.
7. Willing to undergo MRI and screening for metal implants or metal injury.
8. Estimated GFR >29 mL/min
9. Ability to provide informed consent.
10. Willing to return to study site for all study assessments.

Registration-Exclusion Criteria:

1. Prior history of pancreatic cancer.
2. Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
3. Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
4. Hereditary pancreatitis.
5. eGFR < 30 mL/min
6. Contraindication to MRI examination or gadolinium contrast.
7. Pregnant or nursing women.
8. Co-morbid illnesses or other concurrent disease which, in the judgment of the clinicians obtaining informed consent, would make the participant inappropriate for entry into this study.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

FAMILIAL PANCREATIC CANCER and/or GENE MUTATION

An inherited genetic syndrome associated with Pancreatic Cancer and/or with a strong family history of Pancreatic Cancer.

Interventions

MRI/MRCP

An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually

Primary outcome measure

  • Early Stage Pancreatic Cancer or Precursor Lesions [ Time Frame: Through study completion, up to 3 years ]

Central Contacts and Locations

Central contacts

Locations

Nuvance Health

Recruiting

Norwalk, Connecticut, United States, 06856

Contacts

Principal Investigator:

Richard Frank, MD

More Information

Sponsor

Nuvance Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Pancreas
  • Cancer
  • MRI
  • BRCA
  • Early Detection
  • Genetics
  • ATM
  • PALB2
  • Lynch
  • CDKN2A

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nuvance Health on 2026-04-13.