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

NCT00620919 | Terminated Phase 1

• 1 other identifier: 2006P002501
• 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 Multidetector Computed Tomography (MDCT) of the pancreas.
2. 2.To demonstrate that RG1068-enhanced MDCT improves image quality of the pancreas in patients with chronic pancreatitis.
3. 3.To evaluate if RG1068 enhanced MDCT results in improved delineation of structural abnormalities of the pancreatic duct as compared to non-enhanced MDCT.

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• MDCT-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.

  1

Secondary Outcomes (1)

• Laboratory

  2

Study Arms (1)

1

EXPERIMENTAL

Drug + MDCT

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: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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)