Actively Recruiting
Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
Led by Imperial College London · Updated on 2024-10-15
6
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Quantifying 18kDa TSPO Expression in the Lung in Pulmonary Artery Hypertension (PAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) eligible after a negative highly sensitive pregnancy test and use of highly effective contraception other than oral contraceptive pill until end of systemic exposure
- Fertile male participants willing to comply with contraceptive requirements
You will not qualify if you...
- Unable to provide informed consent and/or non-fluent in English
- TT Genotype at the rs6971 locus
- Clinically-significant renal disease (creatinine clearance <30 ml/min per 1.73m2)
- Clinically-significant liver disease (serum transaminases >2 times upper normal limit)
- Anaemia (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
- Received an Investigational Medicinal Product within 5 half-lives or 1 month before baseline
- Participation in research involving significant ionising radiation within last 3 years
- Significant radiation exposure other than dental X-rays in last 1 year
- Positive Allen's test
AI-Screening
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Trial Site Locations
Total: 1 location
1
Imperial Clinical Research Facility
London, United Kingdom, NW3 2LE
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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