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

26. august 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

2000

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Frankrike
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, Frankrike, 69002
        • Har ikke rekruttert ennå
        • Hospices Civils de Lyon - Hôpital Édouard Herriot
        • Ta kontakt med:
        • Hovedetterforsker:
          • Prof. Dr. Laurent Milot
    • Île-de-France Region
      • Créteil, Île-de-France Region, Frankrike, 94000
        • Har ikke rekruttert ennå
        • Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
        • Ta kontakt med:
        • Hovedetterforsker:
          • Prof Dr. Hicham Kobeiter
  • Nederland
    • South Holland
      • Leiden, South Holland, Nederland, 2333 ZA
        • Rekruttering
        • Leiden University Medical Center
        • Ta kontakt med:
        • Hovedetterforsker:
          • Prof. Dr. Mark C. Burgmans
        • Underetterforsker:
          • Dr. Ir. Jouke Dijkstra

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Local tumor control
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall survival
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At time of procedure
Duration of the procedure to evaluate the workflow.
At time of procedure

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mark C Burgmans, MD PhD

Samarbeidspartnere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

28. mai 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

9. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 101252582

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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