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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Emma C.M. Buijsman, MSc
- 電話番号：+31 71 526 49 50
- メール：e.c.m.buijsman@lumc.nl
研究場所
-
-
South Holland
-
Leiden、South Holland、オランダ、2333 ZA
- 募集
- Leiden University Medical Center
-
コンタクト：
- Emma C.M. Buijsman, MSc
- 電話番号：+ 31 71 526 49 50
- メール：e.c.m.buijsman@lumc.nl
-
主任研究者：
- Prof. Dr. Mark C. Burgmans
-
副調査官：
- Dr. Ir. Jouke Dijkstra
-
-
-
-
Auvergne-Rhône-Alpes
-
Lyon、Auvergne-Rhône-Alpes、フランス、69002
- まだ募集していません
- Hospices Civils de Lyon - Hôpital Édouard Herriot
-
コンタクト：
- Prof. Dr. Laurent Milot
- メール：laurent.milot@chu-lyon.fr
-
主任研究者：
- Prof. Dr. Laurent Milot
-
-
Île-de-France Region
-
Créteil、Île-de-France Region、フランス、94000
- まだ募集していません
- Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor
-
コンタクト：
- Prof Dr. Hicham Kobeiter
- メール：hicham.kobeiter@aphp.fr
-
主任研究者：
- Prof Dr. Hicham Kobeiter
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Local tumor control
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Overall survival
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：At time of procedure
|
Duration of the procedure to evaluate the workflow.
|
At time of procedure
|
協力者と研究者
スポンサー
協力者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 101252582
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。