GenderNCT05618119
[18F]MC225 PET to Evaluate Gender Differences in BBB P-gp Function
A study testing [18F]MC225 in people with Gender, run by University Medical Center Groningen.
Trial summary
P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender
- What is being tested?
- [18F]MC225
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers
Who cannot join
- Use of medication with a known effect on the BBB P-glycoprotein transporter
- Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET
P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.
- Conditions
- Gender
- Being tested
- [18F]MC225
- Keywords
- P-glycoprotein, MC225, [18F]MC225, PET
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MC225Drug
[18F]MC225 PET scan
| Study group | Role | What they receive |
|---|---|---|
| Male | Active comparator | 5 male participants will undergo a [18F]MC225 PET scan Receives: Drug: [18F]MC225 |
| Female | Active comparator | 5 female participants will undergo a [18F]MC225 PET scan Receives: Drug: [18F]MC225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET kinetic modeling outcome parameters [18F]MC225
volume of distribution, K1, k2
Measured: 60 minutes after administration [18F]MC225
Secondary outcomes (1)
PET kinetic modeling outcome parameters [15O]H2O
K1 to evaluate Cerebral Blood Flow (CBF)
Measured: 10 minutes after administration of [15O]H2O
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
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 GenderStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups of healthy volunteers (5 male, 5 female)
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gert Luurtsema, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618119
- Sponsor's protocol ID
- 11323
- Status last verified
- Nov 2022
- First submitted
- 8 Nov 2022
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salvi de Souza G, Mossel P, Somsen JF, Providencia L, Bartels AL, Willemsen ATM, Dierckx RAJO, Furini CRG, Lammertsma AA, Tsoumpas C, Luurtsema G. Evaluating image-derived input functions for cerebral [18F]MC225 PET studies. Front Nucl Med. 2025 Jun 5;5:1597902. doi: 10.3389/fnume.2025.1597902. eCollection 2025.
PubMed 40538986
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gender Differences in P-glycoprotein Function Measured With [18F]MC225 and PET
- ClinicalTrials.gov ID
- NCT05618119
- Acronym / sponsor ID
- 11323
- Conditions
- Gender
- Keywords
- P-glycoprotein, MC225, [18F]MC225, PET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 16 Nov 2022 (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.
P-gp is one of the main efflux transporters at the blood-brain barrier and is responsible for the transport of a variety of neurotoxic substances, including pharmaceuticals. Multiple studies report gender differences in therapeutic outcomes, toxicity and side effects for many drug agents. P-gp plays an important role in the bio-availability, drug distribution, metabolism and elimination of pharmaceuticals labelled as P-gp substrates (e.g. the majority of antidepressants and antipsychotics). A difference in P-gp function was already reported in hepatic P-gp expression. The aim of the current study is to evaluate the influence of gender on cerebral P-gp function. Outcomes of this study can be of great importance in gender-based prescription of P-gp substrate pharmaceuticals.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups of healthy volunteers (5 male, 5 female)
| Arm | Type | Receives |
|---|---|---|
| Male | Active comparator | Drug: [18F]MC2255 male participants will undergo a [18F]MC225 PET scan |
| Female | Active comparator | Drug: [18F]MC2255 female participants will undergo a [18F]MC225 PET scan |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (2 listed)
- Use of medication with a known effect on the BBB P-glycoprotein transporter
- Any history of neurological or psychiatric conditions affecting the BBB P-glycoprotein function
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 |
|---|---|---|
| [18F]MC225[18F]MC225 PET scan | Drug | Female, Male |
Primary outcome
PET kinetic modeling outcome parameters [18F]MC225
Time frame: 60 minutes after administration [18F]MC225
volume of distribution, K1, k2
1 secondary outcome
PET kinetic modeling outcome parameters [15O]H2O
Time frame: 10 minutes after administration of [15O]H2O
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Derived from this study: PubMed 40538986Salvi de Souza G, Mossel P, Somsen JF, Providencia L, Bartels AL, Willemsen ATM, Dierckx RAJO, Furini CRG, Lammertsma AA, Tsoumpas C, Luurtsema G. Evaluating image-derived input functions for cerebral [18F]MC225 PET studies. Front Nucl Med. 2025 Jun 5;5:1597902. doi: 10.3389/fnume.2025.1597902. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing [18F]MC225 in people with Gender, run by University Medical Center Groningen.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pascalle Mossel, Msc (+3150 361 6161, p.mossel@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET kinetic modeling outcome parameters [18F]MC225 (time frame: 60 minutes after administration [18F]MC225). 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 NCT05618119, 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 16 Nov 2022; AzTrials last refreshed its copy on 1 Nov 2026.