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

Recruiting

• Conditions: Pulmonary Arterial Hypertension; Healthy
• Interventions: Radiation: TSPO PET scan (11C-PBR28)

• Registration Number: NCT05745961
• Lead Sponsor: Imperial College London

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-16
• Study First Submitted QC: 2023-02-16
• Study First Posted: 2023-02-27
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-14
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PAH	TSPO PET scan (11C-PBR28)	-
Healthy volunteer	TSPO PET scan (11C-PBR28)	-

Primary Outcome Measures

Name	Time	Method
The specific and non-specific fractions of the [11C]PBR28 signal in the lungs of healthy individuals and PAH patients.	2 years

Trial Locations

Locations (1)

Imperial Clinical Research Facility; 🇬🇧 London, United Kingdom