Secretin Enhanced MRCP for Evaluation of Pancreatic Duct in Pediatric Population

NCT00621283 | Terminated Phase 1

• 1 other identifier: 2006P002499
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To demonstrate that RG1068-enhanced MRCP improves image quality relative to unenhanced MRCP in patients with unexplained acute recurrent pancreatitis (ARP) and chronic pancreatitis.
3. 3.To evaluate if the use of RG1068-enhanced MRCP improves structural delineation of the pancreatic duct as compared to the non-enhanced MRCP.
4. 4.To assess pancreatic exocrine function by quantifying pancreatic fluid output into the duodenum and the apparent diffusion coefficient of the pancreas.

Conditions

Acute Recurrent Pancreatitis; Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  1

Secondary Outcomes (1)

• Laboratory

  2

Study Arms (1)

1

EXPERIMENTAL

Drug + MR with MRCP

Drug: RG1068 (Synthetic Human Secretin)

Interventions

RG1068 (Synthetic Human Secretin) DRUG

Dose: 0.2 μg/kg of synthetic human or 18.5 µg for patients over 50 kg Route: Intravenous Frequency: Once Duration: Over 1 minute

1

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Secretin

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Dushyant V Sahani

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 22, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 29, 2009

Record last verified: 2009-01

Locations

US (1)