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

Sponsor: Imperial College London

NCT ID: NCT05745961

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
TSPO PET scan (11C-PBR28) (radiation)
How long the study runs
Study runs about 26 months (dates as stated)
About the drug or intervention
TSPO PET scan (11C-PBR28) — radiation: PET scan
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
25 Years to 75 Years
Who
All
Number of participants
6
Started
2023-02-01
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for pulmonary arterial hypertension
  • • Clinical study - 6 participants
  • • 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

Who can take part?

  • • Ages 25 Years to 75 Years
  • • Diagnosed with pulmonary arterial hypertension

Where?

  • • London - Imperial Clinical Research Facility

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Pulmonary Arterial HypertensionHealthy

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Years - 75 Years
  • Who can join: All genders

Biomarkers mentioned

after a negative

What the study is looking for

  • ✓Able to provide written agreement to take part prior to any study mandated procedures.
  • ✓Able to lie comfortably on back for up to 90 minutes at a time.
  • ✓Male participants who are fertile are eligible to participate if they are willing to comply with the contraceptive...

Who cannot take part

  • ✗Unable to provide agreement to take part and/or are non-fluent speakers of the English language
  • ✗TT Genotype at the rs6971 locus
  • ✗Clinically-significant kidney 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
See the full 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. \-

Where Is This Study? (1 UK site)

Imperial Clinical Research Facility

London NW3 2LE, United Kingdom

Recruiting
Site contact (verified)
Data sourced from ClinicalTrials.gov · Last verified: 2024-10