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Набор скоро начнётся NCT07636148

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

Наблюдательное Liver Cancer (Primary and Metastatic) Lung Cancer (Diagnosis) Bone Cancer Metastatic Bone Cancer Tumor

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Liver Cancer (Primary and Metastatic), Lung Cancer (Diagnosis), Bone Cancer Metastatic, Bone Cancer Tumor. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция, Нидерланды
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prospective Registry of Spectral Angio-CT-Guided Interventional Oncology Procedures in Routine Clinical Practice

Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Local tumor control [Срок оценки: 6 months, 1 year, 2 years, 3 years]
Вторичные конечные точки (5)
  • Overall survival [Срок оценки: 6 months, 1 year, 2 years, 3 years]
  • Progression-free survival [Срок оценки: 6 months, 1 year, 2 years, 3 years]
  • Ablation margin and embolization completeness [Срок оценки: At time of procedure]
  • Incidence of periprocedural adverse events [Срок оценки: 30 days after procedure]
  • Procedure duration [Срок оценки: At time of procedure]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • Patients who are declared incapacitated;
  • Patients suffering from psychic disorders that make a comprehensive judgement impossible.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 2 центра
  • Hospices Civils de Lyon - Hôpital Édouard Herriot — Lyon
  • Assistance Publique Hopitaux de Paris - Hôpital Henri Mondor — Créteil
Нидерланды · 1 центр
  • Leiden University Medical Center — Leiden

Идентификаторы

NCT: NCT07636148 · 101252582

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗