Long-Axial Field of View (LAFOV) [18F]FDG PET/CT Imaging in Large Vessel Vasculitis (LVV): Protocol Optimisation Study.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

About this trial

Large vessel vasculitis (LVV) is an autoimmune inflammatory disorder affecting the major arteries of the body. The diagnosis and monitoring this condition can be challenging, as patients often present with symptoms that are unclear, and the diagnostic criteria currently used are varied. Accurate diagnosis is essential because it helps to tailor the treatment to each patient. Some treatments, such as steroids and immunosuppressive medications, can have significant side effects, so they need to be used carefully and only when truly needed.

An \[18F\]FDG Positron Emission Tomography/Computed Tomography (PET/CT) involves the injection of a small amount of radiolabelled sugar, which assesses glucose metabolism within the body. \[18F\]FDG PET/CT is already used by the NHS to detect inflammation within the vessel walls and diagnose LVV. Current diagnostic criteria for LVV largely rely on visual assessment by a radiologist. This approach therefore has limitations and may not fully capture changes in the levels of inflammation over time.

A new generation of scanners, known as Long Axial Field-of-View (LAFOV)-PET/CT or Total Body PET, are currently transforming what is possible in the field of medical imaging. These LAFOV-PET/CT scanners have new digital detectors that are more sensitive, produce sharper images, and can scan the entire body rapidly. This offers several potential advantages for patients with LVV, including the clearer detection of vessel wall inflammation, the ability to administer lower doses of the radiolabelled sugar (\[18F\]FDG), and the ability to take repeated pictures over time to measure subtle changes in blood flow and inflammation. Patients receiving a routine NHS \[18F\]FDG PET/CT scan for LVV are typically scanned 60 minutes after injection of the radiotracer using a standard PET/CT. Another benefit of LAFOV-PET/CT scanners is their ability to assess the amount of the radiolabelled sugar taken up by the whole body almost as soon as it is injected which could give important additional information.

As part of the LAVA-FLOW study we are planning to combine LAFOV-PET/CT with a CT Angiogram (CTA) in patients with LVV. A CTA is a scan that shows doctors what your blood vessels look like. It involves the injection of a dye into a vein that makes your blood vessels visible, highlighting vessel wall inflammation and vessel wall narrowing. This combination of LAFOV-PET/CT and CTA therefore has the potential to give a much more detailed picture of LVV than is achievable using current methods.

The LAVA-FLOW study therefore aims to develop a standardised protocol to be used in different hospital centres across the UK for the imaging of LVV using LAFOV-PET/CT. We also hope that the results of this particular study could lead to further larger studies with the potential to update the diagnostic criteria and improve the monitoring of this condition.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

≥18 years of age

Newly diagnosed LVV (based on the 2022 American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) classification criteria or from a definite diagnosis of LVV on standard of care imaging)

WHO performance status 0-2

The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained

Disqualifiers

The subject is pregnant or lactating

Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure

History of allergy to iodinated contrast

Commencement of steroids > 7 days prior to administration of the radiotracer

Trial design

Design model

Parallel

Treatments tested in this trial

  • [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT

    Diagnostic test

    All participants will undergo an initial standard dose attenuation correction CT (ACCT) scan. \[18F\]FDG will be administered with a target injected dose of 1.5MBq/kg at 0 minutes in a single IV bolus. The participants will undergo a dynamic LAFOV-PET/CT scan between 0-55 minutes. This will be followed by a 10-minute cardiac-gated static PET/CT scan performed between 60-70 minutes post-injection. A further ACCT (standard dose ACCT for LVV patients \& low dose ACCT for healthy volunteers) followed by delayed static LAFOV-PET/CT will subsequently be performed at +120 minutes post-injection for up to 10 minutes.

  • CT Angiogram

    Diagnostic test

    LVV patients will undergo a CT angiogram. This will take place immediately after their \[18F\]FDG LAFOV-PET/CT.

  • MR Angiogram

    Diagnostic test

    Healthy Volunteers will have an MR angiogram at Imperial College Healthcare NHS Trust. This scan visit will be performed on a separate date following the performance of their LAFOV-PET/CT.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: LVV Patients: [18F]LAFOV-PET/CT & CT AngiogramExperimental treatment 2 interventions
Group B: Healthy Volunteers: [18F]LAFOV-PET/CT & MR AngiogramExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

To investigate [18F]FDG localisation in LVV patients and HVs (controls) on LAFOV-PET/CT.

SUVmax of all vascular segments in the LVV patient cohort versus the HV cohort (60-70 min p.i. data).

Time frame
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG

Secondary outcomes

1

To compare visual, semi-quantitative and quantitative scoring systems in LVV and HV, including smaller calibre vessels using LAFOV-PET/CT.

Summary comparison of visual (PETVAS scoring), semi-quantitative (SUVmax, SUVmean \& tissue to background ratio (TBR) and SUV/TBR) and quantitative (Ki Patlak analysis) scoring systems at 60-70 min p.i.

Time frame
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG
2

To investigate how simulated lower dose acquisitions affect vascular activity and scan quality on LAFOV-PET/CT.

Visual scoring (PETVAS scoring - most diseased and summed vascular segments), and semi-quantitative scoring (SUVmax and TBR) on image data (at 60-70 min p.i.) reconstructed using shorter acquisition times (1, 2, 4, 6, 8 and 10 min).

Time frame
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG
3

To assess the impact of using the CT angiogram (CTA) for attenuation correction in LVV patients on LAFOV-PET/CT.

Summary comparison of visual (PETVAS scoring) and semi-quantitative (SUVmax, SUVmean and TBR) using CTA or attenuation correction CT (ACCT) for the purpose of attenuation correction of the 120-130 min p.i. data (120-130 min static) and 60-70 min p.i. data (60-70 min static).

Time frame
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG
4

To investigate the impact of delayed imaging at 120-minute post-injection on vascular activity on LAFOV-PET/CT.

Summary comparison of visual (PETVAS scoring), semi-quantitative (SUVmax, SUVmean , TBR and SUV/TBR) and quantitative (Ki Patlak analysis) scoring systems at multiple acquisition time points (60-70 min compared to 120-130 min p.i.).

Time frame
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

King's College London

Collaborator

Royal Free Hospital NHS Foundation Trust

Collaborator

Imperial College Healthcare NHS Trust

Collaborator

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