Measuring TSPO Expression in the Lungs of Patients with Pulmonary Arterial Hypertension
Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
Imperial College London · NCT05745961
This study is testing if a special imaging technique can help see how a protein in the lungs behaves in people with pulmonary arterial hypertension compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Imperial College London (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (London) |
| Trial ID | NCT05745961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the expression of the 18kDa translocator protein (TSPO) in the lungs of patients with pulmonary arterial hypertension (PAH) using PET imaging with the radioligand [11C]PBR28. Participants will undergo two PET scans: the first to measure the total TSPO PET signal and the second after administration of an unlabelled TSPO ligand to differentiate between specific and nonspecific signals. This approach may help in non-invasively monitoring the response to therapy in PAH patients compared to age-matched healthy controls.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with pulmonary arterial hypertension who can provide informed consent and meet the study's eligibility criteria.
Not a fit: Patients with clinically significant renal or liver disease, or those unable to provide informed consent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method to monitor treatment responses in patients with pulmonary arterial hypertension.
How similar studies have performed: While this approach is novel in the context of PAH, similar imaging techniques have shown promise in other conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
London
- Imperial Clinical Research Facility — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Martin Wilkins — Imperial College London
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Arterial Hypertension, Healthy