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

Recruiting now

Conditions studied: Pulmonary Arterial Hypertension, Healthy

In brief

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.

Key facts

Study ID

NCT05745961

Run by

Imperial College London

People needed

6

Starts

2023-02-01

Expected to finish

2025-04-01

Last updated by the study team

2024-10-15

Who can join

Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Imperial Clinical Research Facility — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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