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

June 3, 2026 updated by: 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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69002
        • Hospices Civils de Lyon - Hôpital Édouard Herriot
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Laurent Milot
    • Île-de-France Region
      • Créteil, Île-de-France Region, France, 94000
        • Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
        • Contact:
        • Principal Investigator:
          • Prof Dr. Hicham Kobeiter
    • South Holland
      • Leiden, South Holland, Netherlands, 2333 ZA
        • Leiden University Medical Center
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Mark C. Burgmans
        • Sub-Investigator:
          • Dr. Ir. Jouke Dijkstra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local tumor control
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: At time of procedure
Duration of the procedure to evaluate the workflow.
At time of procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

May 28, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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