Al18F-NOTA-octreotide PET Imaging in Neuroendocrine Tumors

What Was Tested

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

The aim of this study is to evaluate the diagnostic performance of Al18F-NOTA-octreotide PET imaging in comparison with the current golden standard, 68Ga-DOTA-somatostatin analog PET, in neuroendocrine tumor patients.

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

The registry classes the interventions as device and drug.

More on the Plan

Part A (main part of the trial): Seventy-five neuroendocrine tumor (NET) patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-somatostin analog (SSA) PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/CT.

Part B: At least 10, possibly up to 20 NET patients (M/F, aged 18 years and older) with a routine clinical 68Ga-DOTA-SSA PET/CT performed in the last three months or scheduled within three months, will undergo a whole-body Al18F-NOTA-octreotide PET/MR.

Who Took Part

The registry lists 85 actual participants 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: Subject is aged over 18 years. Signed Informed Consent. Subject is diagnosed with a histologically and/or cytologically confirmed neuroendocrine tumor of all grades of gastroenteropancreatic, pulmonary, neural crest or unknown primary origin. Subject should have a routine clinical 68Ga-DOTA-SSA PET/CT performed within three months prior to the study scan or scheduled within three months after the study scan.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: subject has had exposure to ionizing radiation (\> 1 msv) in other research studies within the last 12 months; subject is potentially pregnant (urinary hcg test can be performed in case of doubt) or is breast-feeding; subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.

How the Study Was Run

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

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

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

It started in 2020-10-07 with completion listed for 2022-02-08.

It ran at 1 site in Belgium.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Differential detection ratio (DDR) (time frame: 2 years).

It also tracked 11 secondary outcomes, for example Lesion detection rate on the organ level, Lesion uptake, Clinical impact on TNM staging or patient management, Lesion detection rate according to the specific 68Ga-DOTA-SSA used for the routine PET scan, Lesion detection rate according to tumor grade and Overall diagnostic image quality according to a five-point Likert-scale.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3 trial of Octreotide in 85 people.

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

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