Actively Recruiting

Age: 25Years - 75Years
All Genders
NCT05745961

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

Age: 25Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Imperial Clinical Research Facility

London, United Kingdom, NW3 2LE

Actively Recruiting

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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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