- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07636148
Registry of Minimally Invasive Cancer Treatment Using Spectral Angio-CT Image Guidance (PreciseOnco)
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
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Emma C.M. Buijsman, MSc
- Phone Number: +31 71 526 49 50
- Email: e.c.m.buijsman@lumc.nl
Study Locations
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, France, 69002
- Hospices Civils de Lyon - Hôpital Édouard Herriot
-
Contact:
- Prof. Dr. Laurent Milot
- Email: laurent.milot@chu-lyon.fr
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Principal Investigator:
- Prof. Dr. Laurent Milot
-
-
Île-de-France Region
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Créteil, Île-de-France Region, France, 94000
- Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
-
Contact:
- Prof Dr. Hicham Kobeiter
- Email: hicham.kobeiter@aphp.fr
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Principal Investigator:
- Prof Dr. Hicham Kobeiter
-
-
-
-
South Holland
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Leiden, South Holland, Netherlands, 2333 ZA
- Leiden University Medical Center
-
Contact:
- Emma C.M. Buijsman, MSc
- Phone Number: + 31 71 526 49 50
- Email: e.c.m.buijsman@lumc.nl
-
Principal Investigator:
- Prof. Dr. Mark C. Burgmans
-
Sub-Investigator:
- Dr. Ir. Jouke Dijkstra
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Thermal ablation
- Registry
- Cryoablation
- Hepatocellular carcinoma
- Renal cell carcinoma
- Multicenter
- Radiofrequency ablation
- Microwave ablation
- Liver metastases
- Spectral CT
- Transarterial chemoembolization
- Progression-free survival
- Interventional oncology
- Tumor recurrence
- Lung tumors
- Image-guided therapy
- Transarterial embolization
- Transarterial radioembolization
- Dual-layer detector CT
- Angio-CT
- Local tumor control
- Musculoskeletal tumors
Additional Relevant MeSH Terms
- Urogenital Diseases
- Bone Diseases
- Musculoskeletal Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Respiratory Tract Diseases
- Neoplasms by Histologic Type
- Digestive System Neoplasms
- Digestive System Diseases
- Lung Diseases
- Liver Diseases
- Neoplasms, Glandular and Epithelial
- Adenocarcinoma
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Neoplastic Processes
- Urologic Neoplasms
- Carcinoma
- Pathological Conditions, Signs and Symptoms
- Recurrence
- Carcinoma, Hepatocellular
- Lung Neoplasms
- Disease
- Neoplasm Metastasis
- Liver Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Bone Neoplasms
Other Study ID Numbers
- 101252582
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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