MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer
Pancreatic cancer remains the fourth leading cause of cancer-related death in the United
States and is marked by advanced stage at diagnosis and a high mortality rate. Intraductal
papillary mucinous neoplasm, IPMN, is a cystic lesion that can be potentially cancerous,
leading to pancreatic adenocarcinoma. Currently, there is no existing imaging modality that
is both sensitive and cost-effective enough in accurately measuring or detecting
adenocarcinoma and IPMN. Improving the methods used in identification and localization of
this disease is critical.
Secretin, a hormone produced by duodenal mucosal cells increases blood-flow to the pancreas.
Our hypothesis is that as secretin increases blood flow to the pancreas, there will be
increased conspicuity in areas of dysplasia/cancer where there is minimal blood-flow,
enhancing tumor detection. The investigators are conducting a prospective,
randomized-control pilot study of thirty patients with IPMN or pancreatic cancer who are
undergoing surgical resection at Columbia University's Pancreas Center. Fifteen patients
will be randomly selected to undergo S-MRI prior to surgery and fifteen patients will be
selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex,
race and tumor-type. The investigators will first evaluate if secretin allows for increased
tumor conspicuity, enhanced visualization of the lesion, by comparing the calculated tumor
conspicuity of S-MRI to N-MRI groups.
The investigators will then assess if S-MRI imaging allows for increased accuracy in lesion
measurements by looking at the concordance in measurements between S-MRI and tumor specimens
post-resection as compared to the concordance in measurements between N-MRI and tumor
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
Difference in lesion conspicuity between S-MRI and N-MRI
The primary outcome that we are interested in studying is whether S-MRI allows for better tumor detection secondary to anticipated increased conspicuity of tumor due to secretin's effect on increasing blood flow to the normal pancreas as compared to N-MRI. Determining S-MRI's efficacy versus that of N-MRI will be carried out by comparing tumor conspicuity measurements in S-MRI and N-MRI groups. Tumor conspicuity will be measured by calculating the contrast to noise ratio, placing region of interest (ROI) on tumor and adjacent tissue and dividing by image noise.
Elizabeth Hecht, MD
United States: Food and Drug Administration