Secretin Enhanced Multidetector CT Pancreatography for Evaluation of Known or Suspected Chronic Pancreatitis

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Secretin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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