Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients

Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study

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).

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Synthetic Human Secretin; Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Procedure: Secretin-Enhanced Endoscopic Ultrasound

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and older.
• At least two first or two second degree relatives with pancreatic adenocarcinoma (the study subject will be either 10 years younger than the youngest age at which a relative was diagnosed with pancreatic cancer, or the study subject will be at least 25 years of age).
• Fulfills criteria or has undergone genetic testing which confirms BRCA1 (BReast CAncer gene 1), BRCA2 (BReast CAncer gene 2), Familial Atypical Multiple Mole Melanoma, PeutzJeghers, Hereditary nonpolyposis colorectal cancer (HNPCC), Hereditary Pancreatitis, or ataxiatelangiectasia.

Exclusion Criteria:

• Any contraindication to MRI, including but not limited to implanted metal devices (e.g. pacemaker,berry aneurysm clips, neural stimulator or cochlear implants).
• Known pancreatic malignancy or dysplasia.
• Pregnancy.
• History of sensitivity to secretin.
• Creatinine greater than 2.
• Unwillingness or inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Synthetic Human Secretin; Single arm (open label).

Drug: Synthetic Human Secretin; 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 Names: RG1068; Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Other Names: S-MRCP; Procedure: Secretin-Enhanced Endoscopic Ultrasound; Other Names: S-EUS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
S-MRCP and S-EUS Concordance	The primary outcome studied will be the concordance of S-MRCP and S-EUS. Screening will consist of two diagnostic imaging modalities. First, all patients will have S-MRCP in conjunction with contrast-enhanced magnetic resonance imaging (MRI)/magnetic resonance angiography (MRA). All images will be analyzed by a radiologist. Within thirty days, all patients will also undergo EUS with and without secretin enhancement (S-EUS).If the S-EUS shows abnormalities, EUS-guided fine-needle aspiration will be performed. The S-MRCP and EUS image findings will be classified as benign or suspicious/malignant to determine the concordance between imaging techniques. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.	Day 1 and up to 30 days after S-MRCP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Positive Predictive Value of S-MRCP	The secondary outcome endpoints of our study will be positive predictive value of S-MRCP, in comparison with EUS/S-EUS and endoscopic retrograde cholangiopancreatography (ERCP), utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of Cancer Antigen 19-9 (CA 19-9) and oral glucose tolerance tests. Due to poor enrollment, inadequate data was collected for data analysis and therefore data analysis was not conducted. There is no data to report.	Up to 1 year

Collaborators and Investigators

• Sponsor: Elizabeth Hecht
• Investigators: Principal Investigator: Elizabeth Hecht, MD, Columbia University

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Estimate): September 9, 2016
• Last Update Submitted That Met QC Criteria: July 25, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Pancreatic adenocarcinoma; Imaging techniques; Synthetic human secretin; Family history of pancreatic cancer; Pancreatic abnormalities; Early detection and prevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Secretin
• Other Study ID Numbers: AAAC1038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided