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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 January 2013 |
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Main ID: |
NCT01094626 |
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Date of registration:
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25/03/2010 |
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Primary sponsor: |
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Public title:
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Secretin-enhanced Magnetic Resonance Imaging (S-MRI) for Pancreatic Cancer Detection
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Scientific title:
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MRI With Secretin Enhancement to Increase Conspicuity of Pancreatic Cancer |
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Date of first enrolment:
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April 2010 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01094626 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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Countries of recruitment
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United States
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Contacts
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Name:
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Elizabeth Hecht, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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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 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 MI (within 6 weeks)
or poor pulmonary function
- History of sensitivity to secretin
- Pregnancy
- Estimated GFR < 30 mL/min/1.73 m2 (as per MDRD Study equation)
- Unwillingness or inability to provide informed consent.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intraductal Papillary Mucinous Neoplasm
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Pancreatic Cancer
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Intervention(s)
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Drug: Secretin
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Primary Outcome(s)
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Difference in lesion conspicuity between S-MRI and N-MRI
[Time Frame: 30 days]
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Secondary Outcome(s)
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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