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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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17 October 2012 |
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Main ID: |
NCT01371240 |
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Date of registration:
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07/06/2011 |
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Primary sponsor: |
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Public title:
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Secretin-Assisted Computed Tomography Scan and Magnetic Resonance Imaging in Improving Pancreatic Tumor Conspicuity
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Scientific title:
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Evaluation of Efficiency of Secretin-Assisted Computed Tomography Scan and Secretin-Assisted Magnetic Resonance Imaging in Improving Pancreatic Enhancement and Tumor Conspicuity: Prospective Study |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01371240 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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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Hooman Yarmohammadi, MD |
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Address:
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Telephone:
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Email:
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yar.hooman@gmail.com |
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Affiliation:
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Name:
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Hooman Yarmohammadi, MD |
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Address:
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Telephone:
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2168443113 |
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Email:
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yar.hooman@gmail.com |
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Affiliation:
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Name:
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Pablo R Ros, MD MPH PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospitals Case Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients 18 or above will be included in the study.
2. Patients suspected of pancreatic mass or with a known pancreatic mass would be
enrolled in the study.
3. Patients with suspected pancreatic pathology and scheduled for imaging study (CT vs.
MRI) will be included if they had obstructive jaundice, with either a stricture in
the lower common bile duct on magnetic resonance cholangiopancreatography (MRCP) or a
pancreatic mass on ultrasound or other imaging study.
Exclusion Criteria:
1. Patients with known advanced pancreatic tumors and those with previous pancreatic
resection will be excluded.
2. Patients with renal insufficiency: increase Cr level or glomerular filteration rate
(GFR) of less than 45 ml/min/1.73.
3. Patients who demonstrate increase in Cr level or patients with acute renal injury.
4. Claustrophobic or patients who are not able to tolerate MRI.
5. Patients with previous history of contrast allergies.
6. Pregnant patients
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pancreas Cancer
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Intervention(s)
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Drug: Secretin Synthetic Human (RG1068)
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Primary Outcome(s)
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Increase in pancreatic tumor conspicuity.
[Time Frame: one year]
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Pancreatic tumor conspicuity on MRI
[Time Frame: one year]
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Secondary Outcome(s)
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post-injection complications and side effects of secretin
[Time Frame: one year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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