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

What Was Tested

The trial (phase 1) is built around Secretin.

To correlate findings on MRCP with histologically confirmed malignancy.

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

Drug + MR with MRCP.

The registry classes the interventions as drug.

More on the Plan

Until relatively recently, endoscopic retrograde cholangiopancreatography (ERCP) was the primary diagnostic and therapeutic modality for assessing patients with suspected pancreatic disease or abnormalities.

MRCP uses stationary water in biliary and pancreatic secretions as an intrinsic contrast medium, thus facilitating examination of pancreatic and biliary ducts and surrounding tissue.

Conversely, filling defects can indicate the presence of stones or mass lesions.

RG1068 is identical in amino acid sequence to naturally occurring human secretin and differs from porcine secretin in 2 amino acids.

Who Took Part

2 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females older than 18 years of age. 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 able and willing to complete all study procedures specified in the protocol.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: presence of a pancreatic stent; history of sensitivity to any of the ingredients in the study drug; any contraindication to mri procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants).

How the Study Was Run

Design: non-randomized, single-group and open-label.

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 2008-02 with completion listed for 2008-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 1 secondary outcome, for example Laboratory.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Secretin in 2 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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