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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094561
Recruitment Status : Completed
First Posted : March 29, 2010
Results First Posted : September 9, 2016
Last Update Posted : September 9, 2016
Information provided by (Responsible Party):
Elizabeth Hecht, Columbia University

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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

Resource links provided by the National Library of Medicine

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

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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094561

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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Elizabeth Hecht
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Principal Investigator: Elizabeth Hecht, MD Columbia University

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Responsible Party: Elizabeth Hecht, Associate Professor of Clinical Radiology, Columbia University Identifier: NCT01094561    
Other Study ID Numbers: AAAC1038
First Posted: March 29, 2010    Key Record Dates
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:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs