NCT05745961 Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
| NCT ID | NCT05745961 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Imperial College London |
| Condition | Pulmonary Arterial Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 6 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2025-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6 participants in total. It began in 2023-02-01 with a primary completion date of 2025-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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. \-
Contact & Investigator
Martin Wilkins
PRINCIPAL INVESTIGATOR
Imperial College London
Frequently Asked Questions
Who can join the NCT05745961 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 75 Years, studying Pulmonary Arterial Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05745961 currently recruiting?
Yes, NCT05745961 is actively recruiting participants. Visit ClinicalTrials.gov or contact Imperial College London to inquire about joining.
Where is the NCT05745961 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05745961 clinical trial?
NCT05745961 is sponsored by Imperial College London. The principal investigator is Martin Wilkins at Imperial College London. The trial plans to enroll 6 participants.