A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer

What Was Tested

This registered phase 1, phase 2 trial tested Neurotensin.

The aim of this study is to investigate the clinical value of \[18F\]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography (PET/CT) in patients with prostate cancer (PCa).

It had 1 arm (groups): 18F-AlF-NOTA-neurotensin PET/CT (experimental).

One injection of the radioligand 18F-AlF-NOTA-neurotensin Device: PET/CT Following injection of 18F-AlF-NOTA-neurotensin the participants will be subjected to whole body PET/CT.

The registry classes the interventions as drug.

More on the Plan

18F-AlF-NOTA-neurotensin is a radioligand targeting the neurotensinreceptor, which is widely expressed on the cell surface of PCa.

The radioligand can be used for the diagnosis and stage of the PCa.

A total of 5 volunteers and 60 PCa patients will be subjected to a 18F-AlF-NOTA-neurotensin PET/CT scan.

The uptake of 18F-AlF-NOTA-neurotensin in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Who Took Part

65 planned participants were the target.

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

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

Examples of who could join: Histologically and/or clinically confirmed and/or suspicious of PCa. Signed informed consent.

The full record lists 2 inclusion and 0 exclusion criteria.

How the Study Was Run

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

Being open-label, the Neurotensin 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 2018-04-23 with completion listed for 2019-12-30.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): 18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer (time frame: 12 months).

It also tracked 1 secondary outcome, for example 18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Neurotensin in 65 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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