Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis
Stopped early · Phase 1
Conditions studied: Chronic Pancreatitis
In brief
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 demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis. 3. To evaluate if RG1068 enhanced MDCT results in improved delineation of structural abnormalities of the pancreatic duct as compared to non-enhanced MDCT.
Key facts
- Study ID
- NCT00620919
- Run by
- Massachusetts General Hospital
- People needed
- 0
- Starts
- 2008-02-01
- Expected to finish
- 2008-12-01
- Last updated by the study team
- 2009-01-29
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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