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Secretin-Assisted Computed Tomography Scan and Magnetic Resonance Imaging in Improving Pancreatic Tumor Conspicuity

Plain-language guide to NCT01371240: early phase 1 interventional trial of Secretin. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01371240
Phase
early phase 1
Status
withdrawn
Start
2011-06
Completion (planned or actual)
2011-12
Participants
n/a (actual)
Design
na, single-blind, diagnostic
Conditions studied
Pancreas Cancer
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered early phase 1 trial tested Secretin.

Accurate preoperative tumor detection and staging are fundamental for treating patients with pancreatic adenocarcinoma.

On the other hand, patients with localized disease, which is amenable to surgical removal, have the option of operation.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients 18 or above will be included in the study. Patients suspected of pancreatic mass or with a known pancreatic mass would be enrolled in the study.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: patients with known advanced pancreatic tumors and those with previous pancreatic resection will be excluded; claustrophobic or patients who are not able to tolerate mri; patients with previous history of contrast allergies.

How the Study Was Run

Design: single-group and single-blind.

In this single-blind Secretin study one party knew the assignments and the other did not.

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

Those kept unaware of assignments: outcomes assessor.

It started in 2011-06 with completion listed for 2011-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Pancreatic tumor conspicuity on MRI (time frame: one year).

It also tracked 1 secondary outcome, for example post-injection complications and side effects of secretin.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Secretin in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.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.