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

• ClinicalTrials.gov Identifier: NCT01094561
• Recruitment Status: Completed
• First Posted: March 29, 2010
• Results First Posted: September 9, 2016
• Last Update Posted: September 9, 2016
• Sponsor: Elizabeth Hecht
• Information provided by (Responsible Party): Elizabeth Hecht, Columbia University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pancreatic Cancer	Drug: Synthetic Human Secretin; Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Procedure: Secretin-Enhanced Endoscopic Ultrasound	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study
• Study Start Date: July 2006
• Actual Primary Completion Date: February 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

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 Name: RG1068; Procedure: Secretin-Enhanced Magnetic Resonance Cholangiopancreatography; Other Name: S-MRCP; Procedure: Secretin-Enhanced Endoscopic Ultrasound; Other Name: S-EUS

Outcome Measures

Primary Outcome Measures :

1. S-MRCP and S-EUS Concordance [ Time Frame: Day 1 and up to 30 days after S-MRCP ]

   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.

Secondary Outcome Measures :

1. The Positive Predictive Value of S-MRCP [ Time Frame: Up to 1 year ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

Sponsors and Collaborators

Elizabeth Hecht

Investigators

• Principal Investigator: Elizabeth Hecht, MD; Columbia University

More Information

• Responsible Party: Elizabeth Hecht, Associate Professor of Clinical Radiology, Columbia University
• ClinicalTrials.gov Identifier: NCT01094561
• Other Study ID Numbers: AAAC1038
• First Posted: March 29, 2010
• Results First Posted: September 9, 2016
• Last Update Posted: September 9, 2016
• Last Verified: July 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Elizabeth Hecht, Columbia University:

Family history of pancreatic cancer; Pancreatic adenocarcinoma; Imaging techniques; Synthetic human secretin; Pancreatic abnormalities; Early detection and prevention

Additional relevant MeSH terms:

Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Secretin; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs