- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01094626
Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
No Intervention: Controls
Fifteen subjects will be selected as controls, undergoing MRI without secretin-enhancement and matched for age, sex, race and tumor-type.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
45 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elizabeth Hecht, MD, Columbia University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Gastrointestinal Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Secretin
Other Study ID Numbers
- AAAE5847
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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