Recruiting

Observational Study

Sponsor:

Nuvance Health

Code:

NCT03937453

Conditions

Pancreatic Cancer

Pancreatic Neoplasms

Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

MRI/MRCP

Study Details

Brief summary:

The main goal of this study is to explore the relationship between new-onset diabetes mellitus/deteriorating diabetes and a subsequent diagnosis of 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 Cancer

Pancreatic Neoplasms

Diabetes Mellitus

Study ID

NCT03937453

Start date

Jan 19, 2018

Status verified date

Apr, 2026

Completion date

Jan 19, 2028

Anticipated

Primary completion date

Jan 19, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age of at least 50 years.
  • DM of Confirmed Duration: DM diagnosed within the past 12 months AND documentation of prior normal FPG, OGTT or HbA1c levels within the past 2 years. Requirement for HbA1c ≥ 6.5% OR
  • DM of Unconfirmed Duration: DM diagnosed within the past 12 months BUT no prior record of normal FPG, HbA1c or OGTT within the past 2 years. Requirement for HbA1c ≥ 7.0% OR
  • Transition from pre-Diabetes to Diabetes Mellitus within the past 12 months characterized by a change in the HbA1c of ≥ 0.5% OR
  • DM With Only One FDR: DM diagnosed within the past 12 months that is of Confirmed or Unconfirmed Duration, in an individual with 1 FDR. Requirement for HbA1c ≥ 6.5%. OR
  • Deteriorating Diabetes: DM with >2% spike in HbA1c within past 6 months confirmed with repeat testing and NOT associated with weight gain and diabetes medication non-compliance
  • ECOG Performance Status of 0-1.
  • No known contraindications to MRI examination or gadolinium contrast.
  • Willing to undergo MRI and screening for metal implants or metal injury.
  • Ability to provide informed consent.
  • Willing to return to study site for all study assessments.

Exclusion Criteria:

  • Prior history of pancreatic cancer.
  • Presence of metastatic cancer or cancer requiring adjuvant chemotherapy within the past 5 years.
  • Received chemotherapy within the past 6 months. (Hormonal therapy is allowable if the disease free interval is at least 5 years).
  • Hereditary pancreatitis.
  • Use of high dose glucocorticoid steroids (at least 20 mg daily of prednisone) within 3 months of diabetes diagnosis or elevation of HbA1c. Lower doses of steroid use as a cause of glucocorticoid-induced diabetes will be made on a case-by-case basis.
  • Contraindication to MRI examination or gadolinium contrast.
  • Pregnant or nursing women.
  • 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

800 participants

Anticipated

Interventions and Outcome Measures

Arms

New-Onset Diabetes Mellitus

Diabetes Mellitus diagnosed within the past 12 months

Deteriorating Diabetes Mellitus

History of Diabetes Mellitus with recent deteriorating within the past 6 months confirmed with repeat testing and not associated with weight gain or diabetes medication non-compliance

Interventions

MRI/MRCP

An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed at baseline. Further imaging upon recommendation by study committee

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

Tammy Lo, MSN

203-855-3551Tammy.Lo@nuvancehealth.org

Pramila Krumholtz, MSN

203-739-7997Pramila.Krumholtz@nuvancehealth.org

Locations

Nuvance Health

Recruiting

Norwalk, Connecticut, United States, 06856

Contacts

Tammy Lo, MSN

203-855-3551Tammy.Lo@nuvancehealth.org

Principal Investigator:

Richard Frank, MD

More Information

Sponsor

Nuvance Health

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Pancreas
  • Cancer
  • Diabetes Mellitus
  • MRI
  • Early Detection
  • Screening

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.