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Application of Al18F-octreotide PET/CT in Tumors With Positive SSTR Expression

Plain-language guide to NCT05749289: phase 2, phase 3 interventional trial of Octreotide, 400 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05749289
Phase
phase 2, phase 3
Status
recruiting participants
Start
2022-12-20
Completion (planned or actual)
2028-12-20
Participants
400 (estimated)
Design
na, open label (everyone knows who gets what), diagnostic
Conditions studied
SSTR Positive Tumors
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Octreotide.

This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with SSTR positive tumors.

It had 1 arm (groups): Al18F-octreotide PET/CT (experimental).

Al18F-octreotide PET/CT will be performed on patients with suspected or clearly diagnosed SSTR positive tumors . The patients were injected with Al18F-octreotide and underwent PET/CT scan 20\~40min after the injection.

The registry classes the interventions as drug.

More on the Plan

Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans.

It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract.

Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas Hepatocellular carcinoma, and meningioma.

Therefore, the sensitivity and specificity of octreotide imaging is high.

Who Took Part

Enrollment: 400 planned participants were the target.

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 with suspected or clearly diagnosed SSTR positive tumors. Signed written consent. Willing and able to cooperate with all projects in this study.

The full record lists 3 inclusion and 3 exclusion criteria.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Octreotide 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 2022-12-20 with completion listed for 2028-12-20.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Diagnostic value (time frame: through study completion, an average of 1 year]).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Octreotide in 400 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

Octreotide: An 8-amino-acid somatostatin analog (Sandostatin, Mycapssa) used for acromegaly and certain hormone-secreting tumors.

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.