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

NCT06955650 | Completed Early Phase 1

• 1 other identifier: 2017-004466-98
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

oxytocin; positron emission tomografi

Outcome Measures

Primary Outcomes (1)

• Radiation dosimetry of 13N-Oxytocin calculated using MIRDcalc

  Description: Radiation dosimetry will be calculated based on dynamic PET scan data using MIRDcalc software. Organ-specific absorbed radiation doses and effective dose will be reported based on ICRP Publication 103 guidelines. Units of Measure: Millisievert (mSv), milligray (mGy)

  Up to 14 days post-administration

Secondary Outcomes (1)

• Biodistribution of 13N-Oxytocin assessed by PET imaging

  Up to 14 days post-administration

Study Arms (1)

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.

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

Interventions

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

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.

Intranasal 13N-Oxytocin PET Imaging

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy or breast-feeding.
• Metal implanted in the body.
• Diseases of the nose and airways.
• Former or current cancer in the head/neck area where radiation therapy was applied.
• Former or current brain disease.
• Psychiatric diseases.
• Heart disease.
• Other serious chronic or acute disease.
• Substance abuse disorders.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• Tonix Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (1)

• Winterdahl M, Nielsen EN, Hansen SB, Dias AH, Vendelbo MH, Jakobsen S, Yeomans D. First-in-human intranasal [13N]oxytocin PET: evaluation of feasibility, biodistribution, and radiation dosimetry. EJNMMI Res. 2025 Nov 18;15(1):137. doi: 10.1186/s13550-025-01329-0.

  PMID: 41251983 DERIVED

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor in neuroimaging

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: May 2, 2025
• Study Start: April 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

DK (1)