Clinical trial NCT01094561
Conditions: Pancreatic Cancer
Keywords: Family history of pancreatic cancer Pancreatic adenocarcinoma Imaging techniques Synthetic human secretin Pancreatic abnormalities Early detection and prevention
Sponsor: Elizabeth Hecht
Start date: 2006-07-01; Completion date: 2015-03-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: Single arm (open label).
Interventions: intervention 1: Synthetic Human Secretin intervention 2: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography intervention 3: Secretin-Enhanced Endoscopic Ultrasound
Intervention descriptions: intervention 1: 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. intervention 2: None intervention 3: None

Protocol documents: