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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Emma C.M. Buijsman, MSc
- 전화번호: +31 71 526 49 50
- 이메일: e.c.m.buijsman@lumc.nl
연구 장소
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South Holland
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Leiden, South Holland, 네덜란드, 2333 ZA
- Leiden University Medical Center
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연락하다:
- Emma C.M. Buijsman, MSc
- 전화번호: + 31 71 526 49 50
- 이메일: e.c.m.buijsman@lumc.nl
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수석 연구원:
- Prof. Dr. Mark C. Burgmans
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부수사관:
- Dr. Ir. Jouke Dijkstra
-
-
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Auvergne-Rhône-Alpes
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Lyon, Auvergne-Rhône-Alpes, 프랑스, 69002
- Hospices Civils de Lyon - Hôpital Édouard Herriot
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연락하다:
- Prof. Dr. Laurent Milot
- 이메일: laurent.milot@chu-lyon.fr
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수석 연구원:
- Prof. Dr. Laurent Milot
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Île-de-France Region
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Créteil, Île-de-France Region, 프랑스, 94000
- Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
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연락하다:
- Prof Dr. Hicham Kobeiter
- 이메일: hicham.kobeiter@aphp.fr
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수석 연구원:
- Prof Dr. Hicham Kobeiter
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Local tumor control
기간: 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.
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6 months, 1 year, 2 years, 3 years
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall survival
기간: 6 months, 1 year, 2 years, 3 years
|
Time from the index procedure to death from any cause.
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6 months, 1 year, 2 years, 3 years
|
|
Progression-free survival
기간: 6 months, 1 year, 2 years, 3 years
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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
기간: At time of procedure
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Assessment of ablation margins and completeness of embolization using spectral CT imaging, compared to standard CT reconstructions.
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At time of procedure
|
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Incidence of periprocedural adverse events
기간: 30 days after procedure
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Periprocedural complications and adverse events graded according to the Common Terminology Criteria for Adverse Events version 6 (CTCAEv6).
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30 days after procedure
|
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Procedure duration
기간: At time of procedure
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Duration of the procedure to evaluate the workflow.
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At time of procedure
|
공동 작업자 및 조사자
협력자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 101252582
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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