Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot Study
18 Years
65 Years
Both
Pancreatic Cancer
Trial Information
Secretin-Stimulated MRCP as an Early Screening Modality for Pancreatic Ductal Abnormalities in Patients at High Risk for Pancreatic Adenocarcinoma: A Pilot 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 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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Primary outcome: S-MRCP and S-EUS concordance
Outcome Description:
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.
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
Harold Frucht, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Food and Drug Administration
Study ID:
AAAC1038
NCT ID:
NCT01094561
Start Date:
June 2007
Completion Date:
November 2012
Related Keywords:
- Pancreatic Cancer
- Family history of pancreatic cancer
- Pancreatic adenocarcinoma
- Imaging techniques
- Synthetic human secretin
- Pancreatic abnormalities
- Early detection and prevention
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Columbia University Medical Center | New York, New York 10032 |
