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

NCT06955650 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-05-02

No results posted yet for this study

Summary

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.

Conditions

  • Pain, Face

Interventions

DRUG

Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor

13N-Oxytocin is a newly developed radiotracer designed to bind selectively to oxytocin receptors. It is labelled with nitrogen-13, a short-lived positron-emitting isotope, and is administered intranasally to facilitate direct access to the central nervous system via the nasal and trigeminal pathways. This radiotracer is investigational and is not intended to exert pharmacological effects. It is used solely for imaging purposes to assess the distribution and potential receptor binding sites of oxytocin in the human brain and the trigeminal nerve. Following administration, PET imaging is conducted using a hybrid PET/MRI scanner. The imaging procedure enables visualisation of the biodistribution of 13N-Oxytocin in vivo. The PET scan protocol includes dynamic image acquisition to track tracer uptake over time and is used in conjunction with MRI for precise anatomical localisation.

Sponsors & Collaborators

  • Tonix Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Aarhus University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06955650 on ClinicalTrials.gov