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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	25 Years - 75 Years
Gender	All

More 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. -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05745961
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension, Healthy

Arms & Interventions

Arms

: PAH

: Healthy volunteer

Interventions

Radiation: - TSPO PET scan (11C-PBR28)

PET scan

Contact a Trial Team

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