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Registry of Minimally Invasive Cancer Treatment Using Spectral Angio-CT Image Guidance (PreciseOnco)

26 augusti 2026 uppdaterad av: Mark C Burgmans, MD PhD

Prospective Registry of Spectral Angio-CT-Guided Interventional Oncology Procedures in Routine Clinical Practice

This study collects data from patients undergoing minimally invasive, image-guided cancer treatments at participating hospitals in the Netherlands and France. All treatments are performed as standard clinical care and include procedures such as tumor ablation and catheter-based treatments of cancer in the liver, kidney, lung, and bone.

During these procedures, a spectral angio-CT system is used for image guidance. This advanced CT scanner automatically captures additional imaging information beyond what is used in routine clinical decision-making. The goal of this study is to investigate how this additional imaging information is associated with treatment outcomes, and how it can be used in the future to improve treatment planning, procedural guidance, and prediction of treatment results.

No experimental interventions are performed. Participation does not alter the treatment or follow-up patients receive. Data are collected from medical records and imaging systems and stored securely for analysis.

Studieöversikt

Status

Rekrytering

Betingelser

Detaljerad beskrivning

Interventional oncology (IO) is an established component of cancer care, offering minimally invasive, image-guided treatments for solid tumors in organs such as the liver, kidney, lung, and musculoskeletal system. IO procedures include percutaneous techniques such as thermal ablation, as well as catheter-based approaches such as transarterial embolization, chemoembolization, and radioembolization. Compared to surgical approaches, these procedures are associated with lower morbidity and mortality, shorter hospital admissions, and lower costs.

Medical imaging plays a central role throughout the IO workflow, from diagnosis and treatment planning to procedural guidance and post-treatment assessment. One major advancement in this context is the integration of angiography and CT into a single angio-CT system, allowing seamless transitions between real-time fluoroscopy and high-resolution cross-sectional imaging during procedures.

The newest generation of angio-CT systems incorporates spectral CT technology, which enables energy-resolved imaging through dual-layer detector technology. This simultaneously acquires spectral data while providing conventional CT reconstructions, allowing standard workflow and image interpretation to remain unchanged while spectral information is available as additional imaging data. Spectral CT has the potential to enhance lesion detection and tissue characterization, reduce metal artifacts, and improve the accuracy of treatment evaluation compared with conventional CT.

All procedures are performed according to standard clinical care at the participating centers. Study participation does not influence clinical decision-making, treatment strategy, or follow-up. No experimental interventions are performed.

This is a prospective, observational, multicenter, international registry study coordinated by Leiden University Medical Center (LUMC). Participating centers include Leiden University Medical Center (LUMC, the Netherlands), Hospices Civils de Lyon (HCL, France), and Assistance Publique Hôpitaux de Paris (APHP, France). The study is part of the EU-funded PreciseOnco project, which aims to further integrate and optimize imaging and guidance technologies within clinical IO workflows.

Studietyp

Observationell

Inskrivning (Beräknad)

2000

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Frankrike
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrike, 69002
        • Har inte rekryterat ännu
        • Hospices Civils de Lyon - Hôpital Édouard Herriot
        • Kontakt:
        • Huvudutredare:
          • Prof. Dr. Laurent Milot
    • Île-de-France Region
      • Créteil, Île-de-France Region, Frankrike, 94000
        • Har inte rekryterat ännu
        • Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
        • Kontakt:
        • Huvudutredare:
          • Prof Dr. Hicham Kobeiter
  • Nederländerna
    • South Holland
      • Leiden, South Holland, Nederländerna, 2333 ZA
        • Rekrytering
        • Leiden University Medical Center
        • Kontakt:
        • Huvudutredare:
          • Prof. Dr. Mark C. Burgmans
        • Underutredare:
          • Dr. Ir. Jouke Dijkstra

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Adult patients (18 years or older) with solid tumors undergoing clinically indicated minimally invasive cancer treatments at participating centers in the Netherlands and France. Eligible procedures include percutaneous techniques such as thermal ablation, and catheter-based approaches such as transarterial embolization, chemoembolization, and radioembolization, for tumors in organs including the liver, kidney, lung, and musculoskeletal system. The spectral angio-CT must be used as part of standard clinical care during the procedure. Patients who are incapacitated or have psychiatric disorders precluding informed consent are excluded.

Beskrivning

Inclusion Criteria:

  • Age ≥ 18 years;
  • Undergoing a clinically indicated IO procedure with a percutaneous or transarterial approach for solid tumors;
  • Use of spectral angio-CT image guidance as part of standard care;
  • Written confirmed consent.

Exclusion Criteria:

  • Patients who are declared incapacitated;
  • Patients suffering from psychic disorders that make a comprehensive judgement impossible.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Local tumor control
Tidsram: 6 months, 1 year, 2 years, 3 years
Local tumor control at the treated site, assessed at 6 months, 1 year, 2 years, and 3 years after the procedure.
6 months, 1 year, 2 years, 3 years

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall survival
Tidsram: 6 months, 1 year, 2 years, 3 years
Time from the index procedure to death from any cause.
6 months, 1 year, 2 years, 3 years
Progression-free survival
Tidsram: 6 months, 1 year, 2 years, 3 years
Time from the index procedure to disease progression or death from any cause.
6 months, 1 year, 2 years, 3 years
Ablation margin and embolization completeness
Tidsram: At time of procedure
Assessment of ablation margins and completeness of embolization using spectral CT imaging, compared to standard CT reconstructions.
At time of procedure
Incidence of periprocedural adverse events
Tidsram: 30 days after procedure
Periprocedural complications and adverse events graded according to the Common Terminology Criteria for Adverse Events version 6 (CTCAEv6).
30 days after procedure
Procedure duration
Tidsram: At time of procedure
Duration of the procedure to evaluate the workflow.
At time of procedure

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Mark C Burgmans, MD PhD

Samarbetspartners

Assistance Publique - Hôpitaux de Paris
Hospices Civils de Lyon
Philips Electronics Nederland BV
European Commission
Quantum Surgical
Philips Medical Systems
Philips France Commercial
IGEA
Philips GmbH Innovate Technologies
Cardiovascular and Interventional Radiological Society of Europe
Klinikum der Universität Köln
EIBIR - European Institute for biomedical imaging research

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2026

Primärt slutförande (Beräknad)

31 december 2030

Avslutad studie (Beräknad)

31 december 2030

Studieregistreringsdatum

Först inskickad

28 maj 2026

Först inskickad som uppfyllde QC-kriterierna

3 juni 2026

Första postat (Faktisk)

9 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

1 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 101252582

Plan för individuella deltagardata (IPD)

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Nej

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