Status:
TERMINATED
Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Chronic Pancreatitis
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
1. To assess the effect of RG1068 at a dose of 0.2 mcg/kg intravenously (IV) on the diameter of the pancreatic duct when used during Multidetector Computed Tomography (MDCT) of the pancreas. 2. To dem...
Detailed Description
Multidetector Computed Tomography (MDCT) is the mainstay of imaging for patients with acute or chronic pancreatitis, suspected pancreatic neoplasms and post-pancreatic surgery evaluation. The use of m...
Eligibility Criteria
Inclusion
- Males and females older than 18 years of age
- Is clinically indicated for contrast-enhanced MDCT of the pancreas
- Scheduled for MDCT and therapeutic or diagnostic ERCP for the assessment of chronic pancreatitis
- Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions
- Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative urine pregnancy test on the same day, but prior to, study drug administration
- Is able and willing to complete all study procedures specified in the protocol
Exclusion
- Has no clear written indication for contrast enhanced MDCT of the pancreas
- Has a history of hypersensitivity to iodine-containing compounds
- Has congestive cardiac failure (class III-IV in accordance with the classification of the New York Heart Association \[NYHA\])
- Presence of a pancreatic stent
- Is unable to comply with the study requirements including follow-up
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease which, in the opinion of the investigator, precludes study participation
- History of sensitivity to any of the ingredients in the study drug
- Pregnancy
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00620919
Start Date
February 1 2008
End Date
December 1 2008
Last Update
January 29 2009
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114