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

NCT07628075 | Not Yet Recruiting

• 2 other identifiers: EDGE 207455UKRI3893
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Giant Cell Arteritis (GCA); Takayasu Arteritis; Large Vessel Vasculitis

Keywords

Large Vessel Vasculitis; [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT; Angiography; Protocol Optimisation

Outcome Measures

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).

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

Secondary Outcomes (5)

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

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

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

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

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

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

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

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

• To establish normal background FDG uptake in HV controls on LAFOV-PET/CT.

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

Study Arms (2)

LVV Patients: [18F]LAFOV-PET/CT & CT Angiogram

EXPERIMENTAL

Diagnostic Test: [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT; Diagnostic Test: CT Angiogram

Healthy Volunteers: [18F]LAFOV-PET/CT & MR Angiogram

EXPERIMENTAL

Diagnostic Test: [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT; Diagnostic Test: MR Angiogram

Interventions

[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.

Healthy Volunteers: [18F]LAFOV-PET/CT & MR Angiogram; LVV Patients: [18F]LAFOV-PET/CT & CT Angiogram

CT Angiogram DIAGNOSTIC_TEST

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

LVV Patients: [18F]LAFOV-PET/CT & CT Angiogram

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.

Healthy Volunteers: [18F]LAFOV-PET/CT & MR Angiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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
• eGFR of ≥30 (mL/min/1.73m2) within 3 months of \[18F\]FDG injection in subjects who have a history of renal impairment, renal disease, renal transplant or diabetes

You may not qualify if:

• 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
• Poorly controlled diabetic with a blood glucose \>11mmol/L
• Evidence of a significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial.
• Three subjects ≥18 years of age that are also \< 50 years old and three subjects ≥50 years of age
• WHO performance status 0-2
• The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained
• The subject is pregnant or lactating
• Participants with claustrophobia or who are unable to comfortably tolerate the scanning procedure
• Participants with any contra-indication to MRI
• Known allergy to gadolinium-based contrast agents
• History of smoking
• History or current diagnosis of the following medical conditions:

Sponsors & Collaborators

• Imperial College London: lead
• Royal Free Hospital NHS Foundation Trust: collaborator
• King's College London: collaborator
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (3)

Royal Free London NHS Foundation Trust

London, Greater London, NW3 2QG, United Kingdom

Location

King's College London

London, Greater London, SE1 7EH, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, Greater London, W2 1NY, United Kingdom

Location

Related Publications (13)

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  PMID: 33245759 BACKGROUND

• Nielsen BD, Gormsen LC, Hansen IT, Keller KK, Therkildsen P, Hauge EM. Three days of high-dose glucocorticoid treatment attenuates large-vessel 18F-FDG uptake in large-vessel giant cell arteritis but with a limited impact on diagnostic accuracy. Eur J Nucl Med Mol Imaging. 2018 Jul;45(7):1119-1128. doi: 10.1007/s00259-018-4021-4. Epub 2018 Apr 18.

  PMID: 29671039 BACKGROUND

• Ponte C. Classification criteria for large vessel vasculitis. ARP Rheumatol. 2024 Jul-Sep;3(3):170-173. doi: 10.63032/TIRL9893. No abstract available.

  PMID: 39368101 BACKGROUND

• Sari H, Eriksson L, Mingels C, Alberts I, Casey ME, Afshar-Oromieh A, Conti M, Cumming P, Shi K, Rominger A. Feasibility of using abbreviated scan protocols with population-based input functions for accurate kinetic modeling of [18F]-FDG datasets from a long axial FOV PET scanner. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):257-265. doi: 10.1007/s00259-022-05983-7. Epub 2022 Oct 4.

  PMID: 36192468 BACKGROUND

• Knappe L, Bregenzer C, Gozlugol N, Mingels C, Alberts I, Rominger A, Caobelli F. New thresholds in semi-quantitative [18F]FDG PET/CT are needed to assess large vessel vasculitis with long-axial field-of-view scanners. Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):3890-3896. doi: 10.1007/s00259-023-06423-w. Epub 2023 Sep 7.

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• Gheysens O, Jamar F, Glaudemans AWJM, Yildiz H, van der Geest KSM. Semi-Quantitative and Quantitative [18F]FDG-PET/CT Indices for Diagnosing Large Vessel Vasculitis: A Critical Review. Diagnostics (Basel). 2021 Dec 14;11(12):2355. doi: 10.3390/diagnostics11122355.

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• Kang F, Han Q, Zhou X, Zheng Z, Wang S, Ma W, Zhang K, Quan Z, Yang W, Wang J, Zhu P. Performance of the PET vascular activity score (PETVAS) for qualitative and quantitative assessment of inflammatory activity in Takayasu's arteritis patients. Eur J Nucl Med Mol Imaging. 2020 Dec;47(13):3107-3117. doi: 10.1007/s00259-020-04871-2. Epub 2020 Jun 22.

  PMID: 32567005 BACKGROUND

• Slart RHJA; Writing group; Reviewer group; Members of EANM Cardiovascular; Members of EANM Infection & Inflammation; Members of Committees, SNMMI Cardiovascular; Members of Council, PET Interest Group; Members of ASNC; EANM Committee Coordinator. FDG-PET/CT(A) imaging in large vessel vasculitis and polymyalgia rheumatica: joint procedural recommendation of the EANM, SNMMI, and the PET Interest Group (PIG), and endorsed by the ASNC. Eur J Nucl Med Mol Imaging. 2018 Jul;45(7):1250-1269. doi: 10.1007/s00259-018-3973-8. Epub 2018 Apr 11.

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• Wang H, Liu Z, Shen Z, Fang L, Zhang S. Impact of coronary involvement on long-term outcomes in patients with Takayasu's arteritis. Clin Exp Rheumatol. 2020 Nov-Dec;38(6):1118-1126. Epub 2020 Feb 14.

  PMID: 32083549 BACKGROUND

• Rytter S, Dias AH, Munk OL, Gormsen LC. Takayasu's arteritis imaged by a LAFOV PET/CT system: better resolution leads to greater diagnostic certainty. Eur J Nucl Med Mol Imaging. 2025 Jul;52(9):3364-3365. doi: 10.1007/s00259-025-07192-4. Epub 2025 Mar 20. No abstract available.

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  PMID: 31645635 BACKGROUND

• Dejaco C, Ramiro S, Bond M, Bosch P, Ponte C, Mackie SL, Bley TA, Blockmans D, Brolin S, Bolek EC, Cassie R, Cid MC, Molina-Collada J, Dasgupta B, Nielsen BD, De Miguel E, Direskeneli H, Duftner C, Hocevar A, Molto A, Schafer VS, Seitz L, Slart RHJA, Schmidt WA. EULAR recommendations for the use of imaging in large vessel vasculitis in clinical practice: 2023 update. Ann Rheum Dis. 2024 May 15;83(6):741-751. doi: 10.1136/ard-2023-224543.

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• van der Geest KSM, Gheysens O, Gormsen LC, Glaudemans AWJM, Tsoumpas C, Brouwer E, Nienhuis PH, van Praagh GD, Slart RHJA. Advances in PET Imaging of Large Vessel Vasculitis: An Update and Future Trends. Semin Nucl Med. 2024 Sep;54(5):753-760. doi: 10.1053/j.semnuclmed.2024.03.001. Epub 2024 Mar 27.

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MeSH Terms

Conditions

Takayasu Arteritis; Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Aortic Arch Syndromes; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tara D Barwick, MBChB MSc FRCR FRCP

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Taryn Youngstein, BSc MB BS MD (Res) MRCP

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura J McLeavy - Clinical Trial Manager, MSc

CONTACT

0203 313 3720; laura.mcleavy13@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

GB (3)