Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) as Screening in Familial Pancreatic Cancer (CA) Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Elizabeth Hecht, Columbia University
ClinicalTrials.gov Identifier:
NCT01094561
First received: March 25, 2010
Last updated: October 22, 2013
Last verified: June 2012
  Purpose

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).


Condition Intervention
Pancreatic Cancer
Drug: Synthetic Human Secretin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Primary outcome: S-MRCP and S-EUS concordance [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 MRI/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.


Secondary Outcome Measures:
  • Secondary outcome: The positive predictive value of S-MRCP [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The secondary outcome endpoints of our study will be positive predictive value of S-MRCP,in comparison with EUS/S-EUS and ERCP, utilizing surgical pathology as the gold standard. In addition, we will also be looking at the utility of CA 19-9 and oral glucose tolerance tests.


Estimated Enrollment: 25
Study Start Date: June 2007
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secretin
Single arm (open label).
Drug: Synthetic Human Secretin
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.
Other Name: RG1068

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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, 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094561

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

No publications provided

Responsible Party: Elizabeth Hecht, Associate Professor of Clinical Radiology, Columbia University
ClinicalTrials.gov Identifier: NCT01094561     History of Changes
Other Study ID Numbers: AAAC1038
Study First Received: March 25, 2010
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Columbia University:
Family history of pancreatic cancer
Pancreatic adenocarcinoma
Imaging techniques
Synthetic human secretin
Pancreatic abnormalities
Early detection and prevention

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014