Imaging Biomarkers of Pancreatic Function and Disease

PHASE4Enrolling by invitationINTERVENTIONAL
Enrollment

195

Participants

Timeline

Start Date

January 18, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
PancreatitisDiabetes Mellitus
Interventions
DIAGNOSTIC_TEST

Research MRI without administration of intravenous secretin

Participants will undergo a research MRI examination. MRI images will be quantitatively analyzed and will be compared to / used to predict diabetes.

DIAGNOSTIC_TEST

Research MRI with administration of intravenous secretin

Participants will undergo a research MRI examination with intravenous administration of secretin. MRI images will be quantitatively analyzed and will be compared to / used to predict exocrine and endocrine pancreatic insufficiency based on the reference standards of ePFTs or fecal elastase and blood hemoglobin A1c (HbA1c) and fasting glucose, respectively.

GENETIC

Genetic Sequencing

Blood will be drawn to enable gene sequencing for gene mutations associated with heritable pancreatitis. We will assess the association between identified gene variants and the presence of diabetes and will construct models based on identified variants to predict progression to diabetes.

DIAGNOSTIC_TEST

Blood Tests

Research blood draw (for markers of pancreatic endocrine insufficiency)

DIAGNOSTIC_TEST

Stool Tests

Research stool collection (for fecal elastase as a marker of exocrine insufficiency)

OTHER

Survey Completion

Participants will be contacted to complete a survey and their charts will be reviewed annually after research MRI to identify any evidence of subsequent development of pancreatic endocrine insufficiency or progression of pancreatitis. Survey and chart review will occur within +/- 14 days of the anniversary date.

DIAGNOSTIC_TEST

Endoscopic pancreatic function tests (ePFTs)

At least two duodenal fluid aspirates will be collected over 15 minutes following secretin administration. Aspirates will be immediately pH tested and will be submitted for analysis of bicarbonate, enzyme (trypsin, amylase, lipase, chymotrypsin) activity, and total protein.

DRUG

Secretin

"Participants enrolled in Aim 1, Aim 3, and Aim 4 will receive intravenous secretin at a dose of 0.2 mcg/kg (maximum 16 mcg).~Participants in Aim 1 will receive two doses (1 during endoscopy and 1 during MRI). Participants in Aim 3 will receive one dose during MRI.~Participants in Aim 4 will receive two doses (1 during each MRI).~Secretin for intravenous use is FDA-approved for stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of exocrine pancreas dysfunction. Safety and effectiveness of secretin in pediatrics have not been established. However, secretin is routinely used in children at CCHMC at the same dose at which it will be administered for this study."

Trial Locations (1)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT05659147 - Imaging Biomarkers of Pancreatic Function and Disease | Biotech Hunter | Biotech Hunter