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Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01094626
Recruitment Status : Withdrawn (Pharmaceutical company did not decide to renew contract)
First Posted : March 29, 2010
Last Update Posted : June 10, 2016
Information provided by (Responsible Party):
Elizabeth Hecht, Columbia University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Intraductal Papillary Mucinous Neoplasm Drug: Secretin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer
Study Start Date : April 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Experimental
Fifteen subjects will be randomly selected to undergo S-MRI prior to surgery. These subjects would receive Secretin, administered by IV bolus injection over 1 minute followed by a 30 second saline flush.
Drug: Secretin
Subjects will each undergo an S-MRI evaluation, at a dose of 0.2 ucg/kg per exam. Secretin 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

No Intervention: Controls
Fifteen subjects will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type.

Primary Outcome Measures :
  1. Difference in lesion conspicuity between S-MRI and N-MRI [ Time Frame: 30 days ]
    The primary outcome 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.

Secondary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01094626

Sponsors and Collaborators
Elizabeth Hecht
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Principal Investigator: Elizabeth Hecht, MD Columbia University

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Responsible Party: Elizabeth Hecht, Associate Professor of Clinical Radiology, Columbia University Identifier: NCT01094626    
Other Study ID Numbers: AAAE5847
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Elizabeth Hecht, Columbia University:
Pancreatic adenocarcinoma
Intraductal papillary mucinous neoplasm
Imaging techniques
Pancreatic surgical resection
Synthetic human secretin
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs