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Imaging Biomarkers of Pancreatic Function and Disease

StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026v5
  2. 2 versions Re-verified since Feb 5, 2024, no change to tracked fieldsv3-v4
  3. Start date changed from estimate of Dec 2022 to Jan 18, 2023v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study seeks to understand the performance of MRI to characterize pancreatitis and predict chronic complications (endocrine and exocrine) of pancreatitis. Through multiple aims, the investigators will benchmark MRI against relevant reference standards (e.g. endoscopic pancreatic function tests, laboratory data). The investigators will also characterize repeatability of the imaging findings and will work to develop methods to simplify and automate analysis of the MRI images. Research interventions depend on the Aim(s) participants enroll in but include: endoscopic pancreatic function testing (added on to clinically indicated upper GI endoscopy), blood tests, stool tests, gene sequencing, and survey completion. All participants will undergo research MRI examinations, a subset of which will include administration of intravenous secretin.
Trial Details
NCT Number NCT05659147
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Pancreatitis, Diabetes Mellitus
Enrollment 195 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov