Secretin Enhanced MRCP for Evaluation of the Known or Suspected Intraductal Papillary Mucinous Neoplasms of the Pancreas

NCT00621556 | Terminated Phase 1

• 1 other identifier: 2006P002500
• Study Type: interventional
• Target: 2
• 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 detection and characterization of intraductal papillary mucinous neoplasms (IPMN) relative to unenhanced MRCP in patients with suspected IPMN
3. 3.To correlate findings on MRCP with histologically confirmed malignancy

Conditions

Intraductal Papillary Mucinous Neoplasms

Outcome Measures

Primary Outcomes (1)

• MR & 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.

  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: 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 MRCP of the pancreas based on prior imaging features suggestive or suspicious of IPMN (eg. Cystic lesion in the pancreas along the duct, ductal dilatation)
• Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the IPMN
• 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

Interventions

Secretin

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)