Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05745961

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial Clinical Research Facility

London, NW3 2LE, United Kingdom

Location status: Recruiting

Location contact

David Owen, MD PhD

CONTACT

[email protected]

07801140800

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

TSPO PET scan (11C-PBR28)

Radiation

PET scan

Primary outcomes

  1. The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.