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Secretin (ChiRhoStim) Pancreas Perfusion for Pancreatic Adenocarcinoma

Plain-language guide to NCT00587132: phase 1, phase 2 non-randomized trial of Secretin, 4 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT00587132
Phase
phase 1, phase 2
Status
terminated early
Start
2006-11
Completion (planned or actual)
2012-02
Participants
4 (actual)
Design
non-randomized, open label (everyone knows who gets what), diagnostic
Conditions studied
Pancreatic Cancer
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 1, phase 2 trial tested Secretin.

The purpose of this study is to test if secretin-enhanced CT is a useful noninvasive screening tool for pancreatic cancer in a high-risk population.

It had four arms (groups): New Onset Diabetes (experimental), Familial Pancreatic Cancer (experimental), Peutz-Jeghers Syndrome (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Because patients with pancreatic cancer rarely presents with disease specific symptoms until late in the course of the disease, identifying and developing surveillance strategies for early detection of asymptomatic pancreatic cancer is critical.

EUS and fine needle aspirate (FNA) are currently the most accurate non-operative methods of establishing the presence or absence of pancreatic cancer.

Consequently, early pancreatic neoplasms likely result in at least partial occlusion of the duct, leading to subsequent ductal dilation.

The investigators will be able to take advantage of this physiologic effect of secretin, by obtaining multi-planar scans with isotropic resolution using a 64-channel CT system.

Who Took Part

Enrollment: 4 actual participants took part.

It was open to people of any sex aged from 35 years with no upper age limit.

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

Examples of who could join: Persons 35 years old or older with familial pancreatic cancer with 2 or more first degree relatives with pancreatic cancer; OR. Persons 35 years old or older with Peutz-Jeghers syndrome; OR.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: persons with contraindication to iodinated contrast; allergy to iodinated contrast; patients with contraindication to ionizing radiation.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Secretin group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Secretin study: the participants and staff both knew the treatment.

It started in 2006-11 with completion listed for 2012-02.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, non-randomized trial of Secretin in 4 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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.