This trial is active, not recruiting.

Condition pancreatic cancer
Treatment synthetic human secretin
Sponsor Elizabeth Hecht
Start date June 2007
End date April 2014
Trial size 25 participants
Trial identifier NCT01094561, AAAC1038


The aim of our study is to evaluate the utility of 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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Single arm (open label).
synthetic human secretin RG1068
Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. 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.

Primary Outcomes

Primary outcome: S-MRCP and S-EUS concordance
time frame: 1 year

Secondary Outcomes

Secondary outcome: The positive predictive value of S-MRCP
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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, BRCA2, Familial Atypical Multiple Mole Melanoma, PeutzJeghers, 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.

Additional Information

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
Principal investigator Elizabeth Hecht, MD
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 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. 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 MRI/MRA, as well as secretin-enhanced 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 SMRCP, in comparison with EUS and ERCP in identifying neoplasm in those patients who undergo surgical resection during this study.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Columbia University.