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Идёт набор NCT06970275

To Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.

Наблюдательное Prostate Cancers Breast Cancer Head and Neck Cancer Cancer

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: Prostate Cancers, Breast Cancer, Head and Neck Cancer, Cancer. 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
Бельгия, Германия, Нидерланды, Великобритания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Multicentric, Observational, Post-marketing, Registry Study to Assess the Correlation of High-resolution Specimen PET-CT Imaging, Using the XEOS AURA 10 PET-CT, With the Histopathology Results and Long-term Outcome of Patients Undergoing Resective Cancer Surgery.

Обзор

This registry study aims to evaluate the effectiveness and clinical impact of specimen PET-CT imaging by analyzing the correlation between specimen PET-CT images, intraoperative interpretations, and histopathological findings. Additionally, it assesses how these imaging insights influence clinical decision-making and long-term patient outcomes. Through this comprehensive analysis in a real-world setting, the study seeks to generate valuable insights that can enhance specimen evaluation processes and ultimately improve patient care.

Первичные конечные точки

  • To assess the correlation between the specimen PET-CT images and final histopathological examination of the specimen. [Срок оценки: Perioperative]
Вторичные конечные точки (10)
  • To assess the correlation between the intra-operative interpretation of specimen PET-CT images and histopathological examination of the specimen and its impact on clinical decision-making. [Срок оценки: Perioperative]
  • To assess the correlation between long-term follow-up clinical outcome and specimen PET-CT imaging findings. [Срок оценки: From surgery to 3 years long term follow-up]
  • To evaluate the influence of neoadjuvant treatment (NAT) on PET radiotracer uptake in specimen PET-CT imaging. [Срок оценки: Perioperative]
  • To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images. [Срок оценки: Perioperative]
  • To investigate whether preoperatively available information (such as tumor subtype, anatomical location, tumor biology, size, grade or TNM classification) as well as intra-operatively available information influence specimen PET-CT images. [Срок оценки: Perioperative]
  • To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images. [Срок оценки: Perioperative]
  • To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images. [Срок оценки: Perioperative]
  • To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images. [Срок оценки: Perioperative]
  • To investigate the influence of different PET radiotracers, activity, physiological parameters and imaging parameters on PET-radiotracer uptake and image quality in specimen PET-CT images. [Срок оценки: Perioperative]
  • To assess the safety profile of PET-CT imaging procedures. [Срок оценки: From surgery to 3 years long term follow-up]

Критерии участия

Критерии включения

All patients that were scheduled for resective surgery and for whom successful high-resolution PET-CT imaging was performed on their resected specimens using the AURA 10 PET-CT. Successful imaging means that the image contains at least a portion of the primary tumor, the radiotracer injection was correctly executed and there were no technical issues that lead to an uninterpretable PET-CT image. Or all patients that are scheduled for resective surgery and for whom high-resolution PET-CT imaging will be performed on their resected specimens using the AURA 10 PET-CT.

Patients willing to provide informed consent for use of their relevant medical records. For retrospectively included patients with no further Long-Term Follow-Up (LTFU) data collection, a notification will be sent.

Критерии исключения

  • Under the age of 18 years at the time of resective surgery.
  • Women who are pregnant or breastfeeding.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Бельгия · 1 центр
  • AZ Maria Middelares — Ghent
Германия · 1 центр
  • Universitäts-klinikum Essen — Essen
Нидерланды · 1 центр
  • UMCG — Groningen
Великобритания · 1 центр
  • University Hospitals Coventry and Warwickshire (UHCW) NHS Trust — Coventry

Идентификаторы

NCT: NCT06970275 · PETRiS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗