Clinical trial NCT01094626: Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
Official title: MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pancreatic Cancer
Intraductal Papillary Mucinous Neoplasm
Keywords: Pancreatic adenocarcinoma
Intraductal papillary mucinous neoplasm
Imaging techniques
Pancreatic surgical resection
Synthetic human secretin
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate the utility of secretin-enhanced MRI (S-MRI) in detecting and measuring pancreatic lesions in patients with known adenocarcinoma or Intraductal papillary mucinous neoplasm (IPMN) lesions. The hypothesis is that S-MRI is superior to MRI without secretin enhancement (N-MRI) in increasing tumor conspicuity, allowing for improved identification and more accurate measurement of lesions or precursor lesions in the pancreas.

Detailed description: 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. The investigators' 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 subjects with IPMN or pancreatic cancer who are undergoing surgical resection at Columbia University's Pancreas Center. Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery and fifteen subjects 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Histologically confirmed IPMN/pancreatic adenocarcinoma by biopsy or fine needle or suspected IPMN/pancreatic adenocarcinoma based on imaging
* Scheduled for surgical resection
* Willingness to provide informed consent.

Exclusion Criteria:

* Any contraindication to magnetic resonance imaging (MRI), including but not limited to implanted metal devices (e.g. pacemaker, berry aneurysm clips, neural stimulator or cochlear implants)
* Unresectable tumor
* Other abdominal neoplasm in addition to neoplasm in pancreas
* Contraindication to surgery, including but not limited to recent myocardial infarction (MI) (within 6 weeks) or poor pulmonary function
* History of sensitivity to secretin
* Pregnancy
* Estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2 (as per Modification of Diet in Renal Disease (MDRD) Study equation)
* Unwillingness or inability to provide informed consent.

Primary outcomes:
measure: Difference in lesion conspicuity between S-MRI and N-MRI
timeFrame: 30 days
Secondary outcomes:
measure: 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
timeFrame: 45 days
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Elizabeth Hecht, MD
role: PRINCIPAL_INVESTIGATOR
References: