Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
Recruiting · NCT05745961 · Observational (researchers observe without assigning treatment) · Lead sponsor: Imperial College London
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Imperial Clinical Research Facility - London, United Kingdom