Liver Cancer (Primary and Metastatic)PreciseOncoNCT07636148
Registry of Minimally Invasive Cancer Treatment Using Spectral Angio-CT Image Guidance
An observational study of Liver Cancer (Primary and Metastatic) and Lung Cancer (Diagnosis), run by Mark C Burgmans, MD PhD at 3 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer (Primary and Metastatic), Lung Cancer (Diagnosis), Bone Cancer Metastatic
- How many people
- 2,000 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2026to 31 Dec 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients who are declared incapacitated;
- Patients suffering from psychic disorders that make a comprehensive judgement impossible.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
France2 sites, 2 recruiting
- Not yet recruiting
Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
Créteil, Île-de-France Region, 94000
Prof Dr. Hicham Kobeiter, hicham.kobeiter@aphp.fr
Prof Dr. Hicham Kobeiter
- Not yet recruiting
Hospices Civils de Lyon - Hôpital Édouard Herriot
Lyon, Auvergne-Rhône-Alpes, 69002
Prof. Dr. Laurent Milot, laurent.milot@chu-lyon.fr
Prof. Dr. Laurent Milot
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Emma C.M. Buijsman, MSc, + 31 71 526 49 50, e.c.m.buijsman@lumc.nl
Prof. Dr. Mark C. Burgmans
About this study
Official title: 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.
Read the 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.
- Conditions
- Liver Cancer (Primary and Metastatic), Lung Cancer (Diagnosis), Bone Cancer Metastatic, Bone Cancer Tumor, Kidney Tumors, Renal Cancer
- Keywords
- Spectral CT, Dual-layer detector CT, Angio-CT, Image-guided therapy, Interventional oncology, Thermal ablation, Radiofrequency ablation, Microwave ablation, Cryoablation, Transarterial chemoembolization, Transarterial radioembolization, Transarterial embolization, Local tumor control, Tumor recurrence, Progression-free survival, Hepatocellular carcinoma, Liver metastases, Renal cell carcinoma, Lung tumors, Musculoskeletal tumors
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis, Lung Neoplasms, Disease, Carcinoma, Renal Cell, Kidney Neoplasms, Carcinoma, Hepatocellular, Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control
Local tumor control at the treated site, assessed at 6 months, 1 year, 2 years, and 3 years after the procedure.
Measured: 6 months, 1 year, 2 years, 3 years
Secondary outcomes (5)
Overall survival
Time from the index procedure to death from any cause.
Measured: 6 months, 1 year, 2 years, 3 years
Progression-free survival
Time from the index procedure to disease progression or death from any cause.
Measured: 6 months, 1 year, 2 years, 3 years
Ablation margin and embolization completeness
Assessment of ablation margins and completeness of embolization using spectral CT imaging, compared to standard CT reconstructions.
Measured: At time of procedure
Incidence of periprocedural adverse events
Periprocedural complications and adverse events graded according to the Common Terminology Criteria for Adverse Events version 6 (CTCAEv6).
Measured: 30 days after procedure
Procedure duration
Duration of the procedure to evaluate the workflow.
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Primary and Metastatic)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Mark C Burgmans, MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Philips Medical Systems, Philips Electronics Nederland BV, Philips France Commercial, Philips GmbH Innovate Technologies, Quantum Surgical, IGEA, Hospices Civils de Lyon, Assistance Publique - Hôpitaux de Paris, EIBIR - European Institute for biomedical imaging research, Cardiovascular and Interventional Radiological Society of Europe, Klinikum der Universität Köln
- Responsible party
- Sponsor-investigator, Mark C Burgmans, MD PhD, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07636148
- Sponsor's protocol ID
- 101252582
- Acronym
- PreciseOnco
- Status last verified
- Aug 2026
- First submitted
- 28 May 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Spectral Angio-CT-Guided Interventional Oncology Procedures in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT07636148
- Acronym / sponsor ID
- PreciseOnco / 101252582
- Conditions
- Liver Cancer (Primary and Metastatic), Lung Cancer (Diagnosis), Bone Cancer Metastatic, Bone Cancer Tumor, Kidney Tumors, Renal Cancer
- Keywords
- Spectral CT, Dual-layer detector CT, Angio-CT, Image-guided therapy, Interventional oncology, Thermal ablation, Radiofrequency ablation, Microwave ablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Mark C Burgmans, MD PhDUniversity, hospital or other
- Collaborators
- European Commission, Philips Medical Systems, Philips Electronics Nederland BV, Philips France Commercial, Philips GmbH Innovate Technologies, Quantum Surgical, IGEA, Hospices Civils de Lyon, Assistance Publique - Hôpitaux de Paris, EIBIR - European Institute for biomedical imaging research, Cardiovascular and Interventional Radiological Society of Europe, Klinikum der Universität Köln
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who are declared incapacitated;
- Patients suffering from psychic disorders that make a comprehensive judgement impossible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer (Primary and Metastatic) and Lung Cancer (Diagnosis), run by Mark C Burgmans, MD PhD at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma C.M. Buijsman, MSc (+31 71 526 49 50, e.c.m.buijsman@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor control (time frame: 6 months, 1 year, 2 years, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.