Status:
TERMINATED
Secretin Enhanced MRCP for Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Intraductal Papillary Mucinous Neoplasms
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 Magnetic Resonance Pancreatography 2. To demonstrate that RG1068-en...
Detailed Description
Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic disease or abnorma...
Eligibility Criteria
Inclusion
- Males and females older than 18 years of age
- Is clinically indicated for MRCP of the pancreas based on prior imaging features suggestive or suspicious of IPMN (eg. Cystic lesion in the pancreas along the duct, ductal dilatation)
- Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the IPMN
- 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 serum 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
- Presence of a pancreatic stent
- 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
- Any contraindication to MRI procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00621556
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