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Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)

Recruitingn/aAges 25 Years - 75 YearsAllImperial College London
NCT05745961 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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. \-
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What it tests

  • TSPO PET scan (11C-PBR28)
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Where

1 site
Imperial Clinical Research Facility
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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