N/A
N=23
Secretin-Stimulated Magnetic Resonance Cholangiopancreatography (S-MRCP) in Pancreatic Patients
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01094561 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2016
Primary outcome: Primary: S-MRCP and S-EUS Concordance
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Synthetic Human Secretin (Drug); Secretin-Enhanced Magnetic Resonance Cholangiopancreatography (Procedure); Secretin-Enhanced Endoscopic Ultrasound (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Elizabeth Hecht
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY S-MRCP and S-EUS Concordance |
— | — |
| SECONDARY The Positive Predictive Value of S-MRCP |
— | — |
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).
Eligibility 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 (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.
Data sourced from ClinicalTrials.gov (NCT01094561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.