Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01452217
First received: October 10, 2011
Last updated: October 13, 2011
Last verified: October 2011
  Purpose

Alterations in pancreatic blood have been implicated in pancreatic inflammation and pain. Several modalities have been used to assess pancreatic blood flow although some of these methods are invasive, use ionising radiation or intravenous contrast media. This is the first study to utilise non-invasive magnetic resonance imaging to quantify flow within arteries supplying the pancreas and pancreatic perfusion is response to secretin stimulation.


Condition Intervention Phase
Chronic Pancreatitis
Drug: Secretin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Non-invasive MRI to Quantify the Effect of Secretin on Pancreatic Blood Flow and Perfusion in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • Pancreatic perfusion [ Time Frame: 0, 5, 10, 20, 30 and 40 min ] [ Designated as safety issue: No ]
    Overall perfusion of the pancreas


Secondary Outcome Measures:
  • Superior mesenteric artery blood flow [ Time Frame: 0, 5, 10, 20, 30 and 40 min ] [ Designated as safety issue: No ]
    Blood flow in the superior mesenteric artery

  • Gastroduodenal artery blood flow [ Time Frame: 0, 5, 10, 20, 30 and 40 min ] [ Designated as safety issue: No ]
    Blood flow in the gastroduodenal artery

  • Hepatic artery blood flow [ Time Frame: 0, 5, 10, 20, 30 and 40 min ] [ Designated as safety issue: No ]
    Blood flow in the hepatic artery

  • Splenic artery blood flow [ Time Frame: 0, 5, 10, 20, 30 and 40 min ] [ Designated as safety issue: No ]
    Blood flow in the splenic artery


Enrollment: 12
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Secretin Drug: Secretin
Secretin 1 IU/kg over 3 min

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Healthy
  • Able to give informed consent

Exclusion Criteria:

  • Current illness
  • Contraindications to magnetic resonance imaging
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452217

Locations
United Kingdom
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: John Simpson, PhD FRCS University of Nottingham
  More Information

Publications:

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01452217     History of Changes
Other Study ID Numbers: D/07/2010
Study First Received: October 10, 2011
Last Updated: October 13, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Nottingham:
Pancreas
Chronic pancreatitis
Perfusion
Blood flow
Magnetic resonance imaging

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014