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

Plain-language guide to NCT01452217: phase 1 non-randomized trial of Secretin, 12 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01452217
Phase
phase 1
Status
completed
Start
2010-09
Completion (planned or actual)
2011-09
Participants
12 (actual)
Design
non-randomized, open label (everyone knows who gets what), diagnostic
Conditions studied
Chronic Pancreatitis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 1 trial, researchers set out to test Secretin.

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.

It had 1 arm (groups): Secretin (experimental).

The registry classes the interventions as drug.

More on the Plan

Background An alteration in pancreatic blood flow may be important in a number of clinical conditions.

Unfortunately, the measurement of pancreatic blood flow is technically difficult due to the anatomical location of the organ and complex blood supply.

Various methods have been used in an attempt to quantify the blood flow but all have potential drawbacks.

The use of endoscopic and laparoscopic methods are invasive as is the use of intravenous contrast media.

Who Took Part

12 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Able to give informed consent.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: current illness; contraindications to magnetic resonance imaging.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Being open-label, the Secretin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-09 with completion listed for 2011-09.

It ran at 1 site in United Kingdom.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Pancreatic perfusion (time frame: 0, 5, 10, 20, 30 and 40 min).

It also tracked 4 secondary outcomes, for example Gastroduodenal artery blood flow, Hepatic artery blood flow and Splenic artery blood flow.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Secretin in 12 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Secretin compound page, all human trials.

Our Notes on the Compound

Secretin: A 27-amino-acid gut hormone that triggers pancreatic secretion; used as a diagnostic agent in pancreatic function testing.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.