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

ConditionsLiver Cancer (Primary and Metastatic)Lung Cancer (Diagnosis)Bone Cancer MetastaticBone Cancer TumorKidney TumorsRenal CancerHepatocellular Carcinoma (HCC)Renal Cell Carcinoma (Kidney Cancer)Renal Cell Carcinoma (RCC)Musculoskeletal CancersMusculoskeletal TumorsBone TumorsLung Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMark C Burgmans, MD PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients who are declared incapacitated;

Patients suffering from psychic disorders that make a comprehensive judgement impossible.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Local tumor control

Local tumor control at the treated site, assessed at 6 months, 1 year, 2 years, and 3 years after the procedure.

Time frame
6 months, 1 year, 2 years, 3 years

Secondary outcomes

1

Overall survival

Time from the index procedure to death from any cause.

Time frame
6 months, 1 year, 2 years, 3 years
2

Progression-free survival

Time from the index procedure to disease progression or death from any cause.

Time frame
6 months, 1 year, 2 years, 3 years
3

Ablation margin and embolization completeness

Assessment of ablation margins and completeness of embolization using spectral CT imaging, compared to standard CT reconstructions.

Time frame
At time of procedure
4

Incidence of periprocedural adverse events

Periprocedural complications and adverse events graded according to the Common Terminology Criteria for Adverse Events version 6 (CTCAEv6).

Time frame
30 days after procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mark C Burgmans, MD PhD

Lead sponsor

Leiden University Medical Center

Sponsor institution

European Commission

Collaborator

Philips Medical Systems

Collaborator

Philips Electronics Nederland BV

Collaborator

Philips France Commercial

Collaborator

Philips GmbH Innovate Technologies

Collaborator

Quantum Surgical

Collaborator

IGEA

Collaborator

Hospices Civils de Lyon

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

EIBIR - European Institute for biomedical imaging research

Collaborator

Cardiovascular and Interventional Radiological Society of Europe

Collaborator

Klinikum der Universität Köln

Collaborator

Source ClinicalTrials.gov
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