Pain, FaceEarly Phase 1NCT06955650
First-in-man Imaging of a New PET Radiotracer for Oxytocin Receptors
A Early Phase 1 study testing Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor in people with Pain, Face, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Face
- What is being tested?
- Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2021to 30 Jun 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to 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
Who cannot join
- 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.
Show all 9Show fewer
- Heart disease.
- Other serious chronic or acute disease.
- Substance abuse disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-man Imaging of a New PET Radiotracer for Oxytocin Receptors - Biodistribution and Radiation Dosimetry
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.
Read the detailed description
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. It has been used to induce labour via infusion since the 1950s and was previously approved for nasal application to aid lactation, although its effectiveness for this purpose has since been questioned. 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. Oxytocin receptors have been identified in regions of the spinal cord associated with pain transmission in both non-human primates and rodents. Animal studies have provided evidence of oxytocin's analgesic effects, particularly following direct administration into the spinal canal or brain cavities.
Intrathecal administration of oxytocin, as opposed to intravenous delivery, has shown effectiveness in reducing chronic low back pain in humans, potentially involving the body's own opioid system. While direct access to the trigeminal system is challenging due to the skull's structure, a promising alternative is the nasocerebral pathway. This pathway enables certain substances administered nasally to reach central nervous system structures and has been explored as a method for delivering treatments to regions affected by neurodegenerative conditions.
Preliminary research suggests that intranasal delivery of oxytocin leads to pain relief restricted to areas supplied by the trigeminal nerve in both animals and humans. This effect appears to result from the nasal route enabling oxytocin to reach trigeminal receptors directly. In preclinical models, nasal but not systemic administration produced a significant analgesic effect in the face. Similar outcomes were observed in individuals with chronic migraine, where nasal oxytocin administration led to a strong reduction in facial pain. These findings suggest that intranasal oxytocin may work by concentrating in the trigeminal nerve via the nasocerebral route.
The current study aims to evaluate how oxytocin distributed via nasal administration spreads in the body, using positron emission tomography (PET). This imaging technique will allow visualisation of how the compound moves through the body and whether it reaches relevant structures such as the trigeminal nerve. The goal is to better understand how intranasal oxytocin might enable targeted pain relief and potentially support its use in treating conditions related to the trigeminal system.
- Conditions
- Pain, Face
- Being tested
- Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor
- Keywords
- oxytocin, positron emission tomografi
- Medical subject headings
- Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptorDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 14 days post-administration
Secondary outcomes (1)
Biodistribution of 13N-Oxytocin assessed by PET imaging
Description: The biodistribution of 13N-Oxytocin will be assessed using PET imaging in combination with MRI for anatomical localisation. Standardised Uptake Values (SUVs) will be calculated using PMOD software to quantify tracer uptake in predefined brain regions and the trigeminal nerve.
Units of Measure: Standardised Uptake Value (SUV)
Measured: Up to 14 days post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start30 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, FaceStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Michael Winterdahl, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955650
- Sponsor's protocol ID
- 2017-004466-98
- Other IDs
- 2017
- Status last verified
- Apr 2025
- First submitted
- 10 Aug 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41251983
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-man Imaging of a New PET Radiotracer for Oxytocin Receptors - Biodistribution and Radiation Dosimetry
- ClinicalTrials.gov ID
- NCT06955650
- Acronym / sponsor ID
- 2017-004466-98
- Conditions
- Pain, Face
- Keywords
- oxytocin, positron emission tomografi
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Tonix Pharmaceuticals, Inc.
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. It has been used to induce labour via infusion since the 1950s and was previously approved for nasal application to aid lactation, although its effectiveness for this purpose has since been questioned. 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. Oxytocin receptors have been identified in regions of the spinal cord associated with pain transmission in both non-human primates and rodents. Animal studies have provided evidence of oxytocin's analgesic effects, particularly following direct administration into the spinal canal or brain cavities.
Intrathecal administration of oxytocin, as opposed to intravenous delivery, has shown effectiveness in reducing chronic low back pain in humans, potentially involving the body's own opioid system. While direct access to the trigeminal system is challenging due to the skull's structure, a promising alternative is the nasocerebral pathway. This pathway enables certain substances administered nasally to reach central nervous system structures and has been explored as a method for delivering treatments to regions affected by neurodegenerative conditions.
Preliminary research suggests that intranasal delivery of oxytocin leads to pain relief restricted to areas supplied by the trigeminal nerve in both animals and humans. This effect appears to result from the nasal route enabling oxytocin to reach trigeminal receptors directly. In preclinical models, nasal but not systemic administration produced a significant analgesic effect in the face. Similar outcomes were observed in individuals with chronic migraine, where nasal oxytocin administration led to a strong reduction in facial pain. These findings suggest that intranasal oxytocin may work by concentrating in the trigeminal nerve via the nasocerebral route.
The current study aims to evaluate how oxytocin distributed via nasal administration spreads in the body, using positron emission tomography (PET). This imaging technique will allow visualisation of how the compound moves through the body and whether it reaches relevant structures such as the trigeminal nerve. The goal is to better understand how intranasal oxytocin might enable targeted pain relief and potentially support its use in treating conditions related to the trigeminal system.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intranasal 13N-Oxytocin PET Imaging | Experimental | Drug: Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptorThere 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. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor13N-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. | Drug | Intranasal 13N-Oxytocin PET Imaging |
Primary outcome
Radiation dosimetry of 13N-Oxytocin calculated using MIRDcalc
Time frame: Up to 14 days post-administration
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)
1 secondary outcome
Biodistribution of 13N-Oxytocin assessed by PET imaging
Time frame: Up to 14 days post-administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Derived from this study: PubMed 41251983Winterdahl 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.
Related trials for Pain, Face
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
Recruiting
An Innovative Cognitive-Behavioral Treatment For Chronic Orofacial Pain
Chronic Primary Orofacial Pain (CPOP), Persistent Idiopathic Facial Pain (PIFP)
RecruitingPhase 2
Phenotype-based Model for Managing Chronic Post-treatment Pain Among Head and Neck Cancer Survivors: a Pilot Study
Chronic Postsurgical Pain, Chronic Post Cancer Surgery Pain
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Imaging procedure to measure the distribution of a newly developed radiolabeled ligand for the oxytocin receptor in people with Pain, Face, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation dosimetry of 13N-Oxytocin calculated using MIRDcalc (time frame: Up to 14 days post-administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.