Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors

What Was Tested

This registered phase 1 trial tested Octreotide.

The aim of this study is to evaluate the potential of Al18F-1,4,7-triazacyclononane-1,4,7-triacetate-octreotide (Al18F-NOTA-octreotide) as a positron emission tomography (PET) somatostatin receptor imaging agent in patients with neuroendocrine tumors.

It had 1 arm (groups): healthy volunteers and NET patients (experimental).

The registry classes the interventions as device, drug and other.

More on the Plan

In the first part of the study, six healthy volunteers will undergo several sequential whole-body PET/CT scans starting from the moment of tracer injection up to six hours post injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in humans.

Furthermore a first comparison with 68Ga-DOTA peptide PET will be performed.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age between 18 and 65 years. Signed Informed Consent. Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests. Age between 18 and 75 years. Signed Informed Consent.

The full record lists 10 inclusion and 27 exclusion criteria; among the exclusions: subject is currently a user (including ''recreational use'') of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse; subject is unable to refrain from smoking more than 10 cigarettes per day during the study; subject has had exposure to ionizing radiation (\> 1 msv) in other research studies within the last 12 months.

How the Study Was Run

Design: 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 2019-04-11 with completion listed for 2019-10-29.

It ran at 1 site in Belgium.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors (time frame: 1 year).

It also tracked 5 secondary outcomes, for example Dosimetry of Al18F-NOTA-octreotide, Normal-organ and tumor uptake of Al18F-NOTA-octreotide as a function of time, Identify the ideal time point for imaging after Al18F-NOTA-octreotide injection, Safety analysis of Al18F-NOTA-octreotide administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 and Preliminary assessment of lesion targeting by Al18F-NOTA-octreotide as compared to 68Ga-DOTATATE.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Octreotide in 12 people.

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

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.