Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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

1 giugno 2026 aggiornato da: Imperial College London

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Systemic vasculitidies are autoimmune diseases which cause inflammation of blood vessels and are categorised according to the size of blood vessels they predominantly involve. The main forms of LVV are giant cell arteritis (GCA) and Takayasu arteritis (TA).

Various imaging modalities are available for the diagnosis of large vessel vasculitis (LVV): ultrasound, magnetic resonance angiography (MRA), computed tomography angiography (CTA) and [18F]fluorodeoxyglucose ([18F]FDG) PET/CT.

Whilst [18F]FDG PET/CT is established in the diagnostic work up of LVV, the relatively low spatial resolution, radiation exposure, and long imaging times have limited its use especially for assessing smaller calibre vessels and coronary arteries.

Digital long-axial field of view (LAFOV)-PET/CT systems are expected to significantly improve the diagnosis and management of LVV, as their increased sensitivity allows for improved detection of the involvement of smaller calibre vessels and low-grade inflammation, even at shorter scan times and/or reduced tracer doses.

LAFOV-PET/CT has the potential to perform dynamic whole-body imaging from the time of radiotracer injection for detailed analysis of [18F]FDG uptake. Additionally, there is the opportunity to acquire LAFOV-PET/CT images and combine this approach with CT angiogram imaging of the heart and all large vessels within one sitting. At present, determining the involvement of small vessels currently relies on the treating physician requesting a CT angiogram (CTA) in addition to other imaging investigations at diagnosis, which is not currently common practice. A combined protocol of [18F]FDG LAFOV-PET/CT and CTA performed that could be performed at diagnosis and during follow-up may allow the burden of coronary artery disease in this cohort to be fully established and to better define its natural history on treatment. For follow-up response cases, particularly in TA, the potential for using lower radiation does with LAFOV-PET/CT is important to further develop the use of PET/CT in these cohort for surveillance monitoring.

The current European Association of Nuclear Medicine (EANM) and the Society of Nuclear Medicine and Molecular Imaging (SNMMI) guidelines for assessment of LVV on [18F]FDG PET/CT recommend visual interpretation of static images using a 4-point visual scale. Although visual analysis of static [18F]FDG PET/CT data is currently clinically recommended for LVV cases. this has limitations. The improved spatial resolution of LAFOV-PET/CT could lead to higher vessel identification through the use of semi-quantitative analysis methods.

The improved spatial resolution of LAFOV-PET/CT could lead to higher vessel identification and the potential misdiagnosis of LVV in normal vessels compared to standard PET/CT. We will therefore need to consider the use of different thresholds when using LAFOV-PET/CT.

In addition to collecting data from patients diagnosed with LVV, data from healthy volunteers (HV) will help us to establish normal background vessel activity on LAFOV-PET/CT. The HV cohort shall have MR angiography (MRA) instead of CTA to keep radiation doses as low as possible.

This study will establish a protocol for LAFOV-PET/CT imaging and provide pilot data for a larger study, which may lead to changing the current visual reporting criteria for LVV by establishing new reference ranges for disease activity. LAVA-FLOW aims to establish an [18F]FDG LAFOV-PET/CT protocol utilising both dynamic and static imaging in combination with angiography.

Tipo di studio

Interventistico

Iscrizione (Stimato)

18

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Regno Unito
    • Greater London
      • London, Greater London, Regno Unito, NW3 2QG
        • Royal Free London NHS Foundation Trust
        • Investigatore principale:
          • Thomas Wagner, MBBS MSc FRCP
      • London, Greater London, Regno Unito, W2 1NY
        • Imperial College Healthcare NHS Trust
        • Contatto:
        • Investigatore principale:
          • Taryn Youngstein, BSc MB BS MD(Res) MRCP
        • Investigatore principale:
          • Tara Barwick, MBChB MSc FRCR FRCP
      • London, Greater London, Regno Unito, SE1 7EH
        • King's College London
        • Contatto:
        • Investigatore principale:
          • Gary Cook, MBBS MSc MD FRCR FRCP

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria LVV Patients:

  • ≥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

Exclusion Criteria LVV Patients:

  • 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.

Inclusion Criteria Healthy Volunteers:

  • 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

Exclusion Criteria Healthy Volunteers:

  • 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:
  • Diabetes Mellitus
  • Chronic Kidney Disease
  • Atrial Fibrillation
  • Migraines
  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus (SLE)
  • Historic or current prescription of the following medications:
  • Any blood pressure medication
  • Any antipsychotic medication
  • Steroids
  • Weight of ≥75Kg (in order to keep the radiation dose <10mSV for HV)
  • Evidence of any significant medical condition which, in the opinion of the Investigator, makes it undesirable for the HV to participate in the trial
  • Participants that have undergone any imaging investigation that exposes them to radiation within the previous 12 months

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: LVV Patients: [18F]LAFOV-PET/CT & CT Angiogram
Test diagnostico: [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT

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.

Test diagnostico: CT Angiogram
LVV patients will undergo a CT angiogram. This will take place immediately after their [18F]FDG LAFOV-PET/CT.
Sperimentale: Healthy Volunteers: [18F]LAFOV-PET/CT & MR Angiogram
Test diagnostico: [18F]FDG Long-Axial Field of View (LAFOV)-PET/CT

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.

Test diagnostico: MR Angiogram
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To investigate [18F]FDG localisation in LVV patients and HVs (controls) on LAFOV-PET/CT.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
To compare visual, semi-quantitative and quantitative scoring systems in LVV and HV, including smaller calibre vessels using LAFOV-PET/CT.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG
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.
[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.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes post-injection of [18F]FDG
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).
[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.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG
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).
[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.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG
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.).
[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.
Lasso di tempo: [18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG
Summary statistics including confidence intervals of visual (PETVAS scoring) and semi-quantitative (SUVmax, SUVmean , TBR and SUV/TBR) scoring at 60-70 and 120-130 min p.i.
[18F]FDG LAFOV-PET/CT Scan Visit - 60-70 minutes versus 120-130 minutes post-injection of [18F]FDG

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Imperial College London

Collaboratori

King's College London
Royal Free Hospital NHS Foundation Trust
Imperial College Healthcare NHS Trust

Investigatori

  • Investigatore principale: Tara D Barwick, MBChB MSc FRCR FRCP, Imperial College Healthcare NHS Trust
  • Investigatore principale: Taryn Youngstein, BSc MB BS MD (Res) MRCP, Imperial College Healthcare NHS Trust

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 gennaio 2028

Completamento dello studio (Stimato)

1 gennaio 2028

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • EDGE 207455
  • UKRI3893 (Altro numero di sovvenzione/finanziamento: Medical Research Council, UK Research and Innovation)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Arterite di Takayasu

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Zambia

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi