First-in-man Imaging of a New PET Radiotracer for Oxytocin Receptors

What Was Tested

The trial (early phase 1) is built around Oxytocin.

The investigators will test a new positron-emitting radiotracer to determine whether it is suitable for studying the oxytocin receptor by positron emission tomography (PET) in humans.

If suitable, the radiotracer will be used to study the brain and trigeminal nerve in several disorders.

It had 1 arm (groups): Intranasal 13N-Oxytocin PET Imaging (experimental).

There is only one arm. All participants in the study will receive intranasal administration of a novel radiolabelled compound, 13N-Oxytocin, developed to selectively bind to oxytocin receptors. Following administration, participants will undergo positron emission tomography (PET) imaging to evaluate the in vivo distribution of the tracer, with a focus on uptake in the brain and trigeminal nerve regions.

The registry classes the interventions as drug.

More on the Plan

The nine amino acid peptide oxytocin was first isolated in 1927 and is primarily recognised for its hormonal role in uterine contractions, lactation, and social bonding.

Oxytocin is also involved in the modulation of pain within the body.

It has been localised to the human dorsal root and trigeminal ganglia, and the terminals of hypothalamic neurons containing oxytocin-specific carrier proteins have been found in the dorsal horn of the spinal trigeminal nucleus.

Animal studies have provided evidence of oxytocin's analgesic effects, particularly following direct administration into the spinal canal or brain cavities.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to people of any sex aged from 35 years up to 50 years.

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

Examples of who could join: Female or male age 35-50 (Women of childbearing potential must use birth control and test negative for pregnancy prior to enrollment in this study). Normal anatomy in nasal region evaluated with MRI. Normal sensory function evaluated with "The Sniffin' Sticks Olfactory Test-Kits.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: pregnancy or breast-feeding; metal implanted in the body; diseases of the nose and airways.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Oxytocin 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 2021-04-30 with completion listed for 2022-06-30.

It ran at 1 site in Denmark.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Radiation dosimetry of 13N-Oxytocin calculated using MIRDcalc (time frame: Up to 14 days post-administration).

It also tracked 1 secondary outcome, for example Biodistribution of 13N-Oxytocin assessed by PET imaging.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Oxytocin in 6 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 Oxytocin compound page, all human trials.