Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The aim of our study is to evaluate the utility of Secretin-Stimulated Magnetic Resonance
      Cholangiopancreatography (S-MRCP) in detecting carcinoma and precancerous lesions in patients
      with a significant family history of pancreatic adenocarcinoma. Our hypothesis is that S-MRCP
      is superior to traditional computed tomography (CT) or magnetic resonance imaging (MRI) in
      detecting early pancreatic neoplasms, and approaches the accuracy of endoscopic ultrasound
      (EUS).
    

Detailed description: 
      Pancreatic cancer remains the fourth leading cause of cancer-related death in the United
      States, largely due to the lack of accurate and cost-effective screening methods. Initial
      screening efforts should be directed at patients with known increased genetic risk for
      pancreatic adenocarcinoma. About 10-20% of pancreatic cancers are considered familial or
      syndromic. Since pancreatic adenocarcinoma is known to progress from preneoplastic lesions,
      termed pancreatic intraepithelial neoplasia (PanIN), it may eventually be possible to
      identify and cure patients by detecting preneoplastic lesions. Traditional radiological
      methods lack the resolution to detect early lesions. The sensitivity and specificity of
      endoscopic retrograde cholangiopancreatography (ERCP) (92%,96%) and EUS (93-98%)are better,
      but these procedures are invasive and limited in availability. Magnetic resonance
      cholangiopancreatography (MRCP) has emerged as a widely-accepted alternative with comparable
      sensitivity to ERCP. Magnetic Resonance Cholangiopancreatography (MRCP) has been further
      augmented by secretin stimulation, which improves visualization of the pancreatic duct as
      well as side branches. We will recruit 25 patients for a prospective pilot study examining
      S-MRCP as a screening technique in high-risk individuals. All recruited patients will undergo
      S-MRCP in conjunction with magnetic resonance imaging (MRI)/magnetic resonance angiography
      (MRA), as well as secretin-enhanced EUS (S-EUS). Those patients with abnormalities on S-MRCP
      or S-EUS will undergo ERCP. If ERCP also shows abnormalities, these patients will be
      recommended total or subtotal pancreatectomy. The primary outcome that we will be studying
      will be concordance of S-MRCP and EUS. Secondarily, we will be measuring positive predictive
      value of S-MRCP, in comparison with EUS and ERCP in identifying neoplasm in those patients
      who undergo surgical resection during this study.
    

Intervention name(s): Synthetic Human Secretin; Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Secretin-Enhanced Endoscopic Ultrasound
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Subjects will each undergo a Secretin-Enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and a Secretin-Enhanced Endoscopic Ultrasound (S-EUS) evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Other intervention name(s): RG1068; S-MRCP; S-EUS
Intervention MeSH terms: Secretin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Family history of pancreatic cancer; Pancreatic adenocarcinoma; Imaging techniques; Synthetic human secretin; Pancreatic abnormalities; Early detection and prevention