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Completed

NCT Number: NCT01094561

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Synthetic Human Secretin

Drug

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

Secretin-Enhanced Magnetic Resonance Cholangiopancreatography

Procedure

Other names: S-MRCP

Secretin-Enhanced Endoscopic Ultrasound

Procedure

Other names: S-EUS

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Elizabeth Hecht

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2010
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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