Validation of the Analysis Methodology Behind the Use of Quantitative 18F-FDG PET/CT to Assess Lung Inflammation

UnknownOBSERVATIONAL
Enrollment

36

Participants

Timeline

Start Date

January 23, 2018

Primary Completion Date

January 31, 2022

Study Completion Date

January 31, 2022

Conditions
Lung InflammationSarcoidosis
Interventions
RADIATION

PET/CT scan

"PET/CT will be performed at Cambridge University Hospital's PET-CT unit, Cambridge.~Participants in Part A of the study (sarcoidosis and HVs) will receive one PET/CT scan. A Cine-CT scan will be performed immediately prior to the 18F-FDG PET/CT scan. Settings for the CT scans will be determined by clinical protocols, radiation dose will be kept as low as reasonably practicable (ALARP) consistent with UK legislation.~After 6 hours of fasting and if blood glucose concentration is ≤11mmol/L participants will proceed to undergo an 18FDG PET/CT scan.~18F-FDG will be administered intravenously at a dose of approximately 200 MBq.~Positron emission scanning will involve a 60-minute dynamic acquisition from the lungs."

OTHER

LPS Challenge

In Part B, eight healthy volunteers will undergo an LPS challenge whereby each participant is injected with the challenge agent, Lipopolysaccharide (LPS), to invoke temporary mild lung inflammation. Each participant will have a PET/CT scan before and after the administration of LPS and the images will be assessed to determine whether these methods are able to detect true lung inflammation.

OTHER

Saline Challenge

In Part B, four healthy volunteers will undergo a saline challenge as outlined above for the LPS challenge. Pre- and post-challenge scans will provide control data for the study.

DIAGNOSTIC_TEST

Blood and urine sampling

For women whose post-menopausal status and/or pregnancy status is uncertain at screening, a blood sample will be collected to test for pregnancy and menopausal status (hormone profiling) before enrolling them on to the study. If pregnancy status is still uncertain at study visits, participants will have a urine pregnancy test before undergoing any PET/CT scans to ensure it is safe for them to continue in the study.

Trial Locations (2)

CB2 0QQ

RECRUITING

Cambridge University Hospitals NHS Foundation Trust, Cambridge

CB23 3RE

RECRUITING

Royal Papworth Hospital NHS Foundation Trust, Papworth Everard

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Cambridge University Hospitals NHS Foundation Trust

OTHER

NCT03312712 - Validation of the Analysis Methodology Behind the Use of Quantitative 18F-FDG PET/CT to Assess Lung Inflammation | Biotech Hunter | Biotech Hunter