Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer|
- Difference in lesion conspicuity between S-MRI and N-MRI [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
- Concordance of tumor measurements between S-MRI images and tumor specimens post-resection vs. concordance of tumor measurements between N-MRI and tumor specimens post-resection [ Time Frame: 45 days ] [ Designated as safety issue: No ]The secondary outcome will be the discrepancy in tumor size estimated from MRI and "confirmed" from post-surgical specimens. Tumor size estimated from MRI scans will be determined by measuring the greatest linear dimension (metric) of the lesion. Tumor size estimated by pathology will be directly measured using a linear scale (metric), taking the greatest linear dimension of the resected tumor. The discrepancy in estimated versus "confirmed" tumor size will be compared between S-MRI and N-MRI groups.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Single arm (randomized).
A minimum of 15 patients, maximum of 30 patients, will each undergo an S-MRI 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 1 minute followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
Other Name: RG1068
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 specimens post-resection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094626
|Principal Investigator:||Elizabeth Hecht, MD||Columbia University|