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Not yet recruiting NCT07636148

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

Observational Liver Cancer (Primary and Metastatic) Lung Cancer (Diagnosis) Bone Cancer Metastatic Bone Cancer Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Liver Cancer (Primary and Metastatic), Lung Cancer (Diagnosis), Bone Cancer Metastatic, Bone Cancer Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Primary outcome measures

  • Local tumor control [Time frame: 6 months, 1 year, 2 years, 3 years]
Secondary outcome measures (5)
  • Overall survival [Time frame: 6 months, 1 year, 2 years, 3 years]
  • Progression-free survival [Time frame: 6 months, 1 year, 2 years, 3 years]
  • Ablation margin and embolization completeness [Time frame: At time of procedure]
  • Incidence of periprocedural adverse events [Time frame: 30 days after procedure]
  • Procedure duration [Time frame: At time of procedure]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 2 centers
  • Hospices Civils de Lyon - Hôpital Édouard Herriot — Lyon
  • Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor — Créteil
Netherlands · 1 center
  • Leiden University Medical Center — Leiden

Identifiers

NCT: NCT07636148 · 101252582

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗