Pulmonary Arterial HypertensionNCT05745961
Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
An observational study of Pulmonary Arterial Hypertension and Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine whether there is an increase in the TSPO PET signal (measured with the radioligand [11C]PBR28) in the lungs of patients living with PAH relative to age matched controls. If so, TSPO PET may be a useful technique to non-invasively monitor response to therapy. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Pulmonary Arterial Hypertension, Healthy
- What is being tested?
- TSPO PET scan (11C-PBR28)
- Type of treatment
- Surgery or procedure
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2023to Apr 2025
- Phase
- Observational
- 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 25 to 75 years
- All sexes
- Adult, Older adult
Study population: PAH patients and healthy volunteers
Who may be able to join
- Able to provide written informed consent prior to any study mandated procedures.
- Able to lie comfortably on back for up to 90 minutes at a time.
- Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill until the end of relevant systemic exposure.
- Male participants who are fertile are eligible to participate if they are willing to comply with the contraceptive requirements
Who cannot join
- Unable to provide informed consent and/or are non-fluent speakers of the English language
- TT Genotype at the rs6971 locus
- Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per 1.73m2)
- Clinically-significant liver disease (confirmed by serum transaminases >2 times than upper normal limit)
- Anaemia confirmed by haemoglobin concentration <10 g/dl
- Sickle cell disease or thalassaemia
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- History of uncontrolled systemic hypertension
- Acute infection (including eye, dental, and skin infections)
- Chronic inflammatory disease including HIV, and Hepatitis B
- Women of childbearing potential who are pregnant or breastfeeding
- Patients who have received an Investigational Medicinal Product (IMP) within 5 half-lives of the last dose of the IMP or 1 month (which ever is greater) before the baseline visit
- Participation in a research study involving significant ionisation radiation within the last 3 years
- Significant radiation exposure other than dental X-rays in last 1 year
- Positive Allen's test.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial Clinical Research Facility
London, NW3 2LE
David Owen, MD PhD, 07801140800, d.owen@imperial.ac.uk
About this study
The aim of this study is to determine whether there is an increase in the TSPO PET signal (measured with the radioligand [11C]PBR28) in the lungs of patients living with PAH relative to age matched controls. If so, TSPO PET may be a useful technique to non-invasively monitor response to therapy. To do this, we will perform 2 [11C]PBR28 PET scans. The first will quantify the total [11C]PBR28 PET signal. This signal is a combination of the specific signal (VS) and the nonspecific signal (VND). The second scan will be performed following dosing with an unlabelled TSPO ligand. By directly measuring the total [11C]PBR28 signal (scan 1) and the nonspecific [11C]PBR28 signal (scan 2) we can therefore calculate the specific [11C]PBR28 signal, and hence the amount of TSPO in the lung.
- Conditions
- Pulmonary Arterial Hypertension, Healthy
- Being tested
- TSPO PET scan (11C-PBR28)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TSPO PET scan (11C-PBR28)Radiation
PET scan
| Study group | Role | What they receive |
|---|---|---|
| PAH | Not described Receives: Radiation: TSPO PET scan (11C-PBR28) | |
| Healthy volunteer | Not described Receives: Radiation: TSPO PET scan (11C-PBR28) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Wilkins, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745961
- Sponsor's protocol ID
- 22HH8097
- Status last verified
- Oct 2024
- First submitted
- 16 Feb 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
- ClinicalTrials.gov ID
- NCT05745961
- Acronym / sponsor ID
- 22HH8097
- Conditions
- Pulmonary Arterial Hypertension, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 27 Feb 2023 (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 aim of this study is to determine whether there is an increase in the TSPO PET signal (measured with the radioligand [11C]PBR28) in the lungs of patients living with PAH relative to age matched controls. If so, TSPO PET may be a useful technique to non-invasively monitor response to therapy. To do this, we will perform 2 [11C]PBR28 PET scans. The first will quantify the total [11C]PBR28 PET signal. This signal is a combination of the specific signal (VS) and the nonspecific signal (VND). The second scan will be performed following dosing with an unlabelled TSPO ligand. By directly measuring the total [11C]PBR28 signal (scan 1) and the nonspecific [11C]PBR28 signal (scan 2) we can therefore calculate the specific [11C]PBR28 signal, and hence the amount of TSPO in the lung.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAH | – | Radiation: TSPO PET scan (11C-PBR28) |
| Healthy volunteer | – | Radiation: TSPO PET scan (11C-PBR28) |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- PAH patients and healthy volunteers
Key inclusion criteria (4 listed)
- Able to provide written informed consent prior to any study mandated procedures.
- Able to lie comfortably on back for up to 90 minutes at a time.
- Fertile females (women of childbearing potential) are eligible to participate after a negative highly sensitive pregnancy test, if they are taking a highly effective method of contraception other than the oral contraceptive pill until the end of relevant systemic exposure.
- Male participants who are fertile are eligible to participate if they are willing to comply with the contraceptive requirements
Key exclusion criteria (15 listed)
- Unable to provide informed consent and/or are non-fluent speakers of the English language
- TT Genotype at the rs6971 locus
- Clinically-significant renal disease (confirmed by creatinine clearance <30 ml/min per 1.73m2)
- Clinically-significant liver disease (confirmed by serum transaminases >2 times than upper normal limit)
- Anaemia confirmed by haemoglobin concentration <10 g/dl
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 |
|---|---|---|
| TSPO PET scan (11C-PBR28)PET scan | Radiation | Healthy volunteer, PAH |
Primary outcome
The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Martin Wilkins principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and Healthy, run by Imperial College London at 1 site in United Kingdom.
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 4 inclusion and 15 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 15 Oct 2024. 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 United Kingdom. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.