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

Launched by IMPERIAL COLLEGE LONDON · Feb 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a specific process in the lungs of patients with Pulmonary Arterial Hypertension (PAH) to see if a certain imaging technique, called TSPO PET, can help us understand their condition better. The researchers want to find out if patients with PAH have higher levels of a specific signal in their lungs compared to healthy individuals of a similar age. If this is true, TSPO PET could be a helpful tool for doctors to monitor how well treatments are working without needing invasive procedures.

To participate in this study, individuals must be able to give informed consent and lie comfortably on their back for up to 90 minutes during the scans. Eligible participants include both men and women, including those who are fertile, as long as they meet certain health criteria. However, individuals with specific medical conditions, such as significant kidney or liver disease, or those who are pregnant or breastfeeding, cannot join. Participants will undergo two PET scans, and the study will help determine if TSPO PET can be a useful way to track PAH over time.

Gender

ALL

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.
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