drugset / Trial / NCT00621283

Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

NCT00621283 ↗

Phase 1 Terminated Massachusetts General Hospital
Non-randomizedSingle-groupOpen-labelDiagnostic

Summary

1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Magnetic Resonance Pancreatography. 2. To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis. 3. To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP. 4. To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.

Timeline

Start
2008-02
Primary completion
2008-12
Completion
2008-12

Outcome

Outcome not reported

Stopped (Enrollment): “Poor patient enrollment due to logistical issues”

Drugs

EvaluationDrugModalityDoseRoute
Subject RG1068 Peptide 0.2 ug/kg Intravenous
Subject RG1068 Peptide 18.5 ug Intravenous