Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00621283
• Date of registration: 22/01/2008
• Prospective Registration: Yes
• Primary sponsor: Massachusetts General Hospital
• Public title: Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population
• Scientific title: RG1068 (Synthetic Human Secretin) Enhanced MRCP for Morphological Evaluation of the Pancreatic Duct in the Pediatric Population
• Date of first enrolment: February 2008
• Target sample size: 0
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00621283
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Dushyant V Sahani
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Males and females 2-18 years of age

- Is clinically indicated for MRCP of the pancreas based on clinical criteria

- Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the assessment
of chronic pancreatitis or acute recurrent pancreatitis (Children with a single
episode of pancreatitis will not be included)

- Parent or legal guardian 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 Criteria:

- 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)



Age minimum: 2 Years
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Recurrent Pancreatitis

Chronic Pancreatitis

Intervention(s)

Drug: RG1068 (Synthetic Human Secretin)

Primary Outcome(s)

MR and MRCP - Images will be evaluated for quality, main and branch duct visualization, ductal diameter and improved visualization of structural abnormalities with and without use of RG1068. Pancreatic exocrine function will be assessed. [Time Frame: 1]

Secondary Outcome(s)

Laboratory [Time Frame: 2]

Secondary ID(s)

2006P002499

Source(s) of Monetary Support

Please refer to primary and secondary sponsors