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Идёт набор NCT06363435

AI-based Measurements of Tumour Burden in PSMA PET-CT

Наблюдательное Prostate 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
В протоколе указаны: AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans.
Кому может быть актуально
Состояния в реестре: Prostate Cancer. Базовые параметры: 20 лет — 120 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Prognostic Value of AI-based Measurements of Tumour Burden in PSMA PET-CT in Patients With Prostate Cancer

Обзор

The primary aim of the present study is to evaluate how automatically calculated (by an AI-based method) tumour burden, measured as tumour volume (TV) and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence).

Подробное описание

In Sweden, prostate cancer is diagnosed in 10,000 men annually and the mortality rate of 2,400 is among the highest worldwide. Some prostate cancers are at high risk of metastatic progression to lethal disease and require correct staging or detection of recurrence and multidisciplinary treatments.

The investigators have developed an AI-based method to detect and quantify tumours and metastases in 18F-PSMA-1007 PET-CT scans in patients with prostate cancer. The method can find tumours in the prostate and metastases in pelvic lymph nodes, distant lymph nodes and in bone, both in patients referred to the PET-CT scan for primary staging of high-risk prostate cancer for secondary staging due to recurrence.

Patients referred to clinically indicated PSMA PET-CT due to either initial staging of primary high-risk prostate cancer or due to biochemical recurrence will be eligible for inclusion. The AI-based method will automatically calculate TV, TU and number of suspected lesions and this information will be stored in a database. The values will after a 5 year follow-up period be analysed with regard to overall survival (OS) and progression-free survival (PFS).

The primary aim of the present study is to evaluate how tumour burden, measured as TV and as tumour uptake (TU: TV x SUVmean) in the prostate/prostate bed, pelvic lymph nodes, distant lymph nodes, bone and as the total tumour burden predicts overall survival (OS) in patients with prostate cancer (newly diagnosed and patients with biochemical recurrence). A secondary aim is to evaluate how the AI-derived measurements predict time to biochemical recurrence in a sub-cohort of patients with newly diagnosed high-risk prostate cancer. Tertiary aims are to evaluate the difference in TV and TU measured with two different segmentation methods (a threshold of 50% of SUVmax in each lesion and a threshold of SUV 4) in relation to OS and biochemical PFS. The impact of the number of automatically calculated suspected lesions will also be investigated regarding OS and biochemical PFS as well as to the difference in tumour burden measured with AI and manually.

Вмешательства

  • Устройство AI-based detection and quantification of suspected tumour/metastases in PSMA PET/CT scans
    Tumour burden will be automatically calculated and stored in a database. The result of the AI-based measurements will not involve the handling of the patients

Первичные конечные точки

  • Tumour burden (cm3) in relation to overall survival [Срок оценки: 5-year follow-up]
Вторичные конечные точки (4)
  • Tumour burden (cm3) in relation to biochemical recurrence [Срок оценки: 5 years]
  • Number of tumours/metastases in relation to OS [Срок оценки: 5 years]
  • Comparing two different segmentation methods in relation to OS [Срок оценки: 5 years]
  • Comparing total tumour burden (cm3) measured manually and by the AI-based mehtod [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Patients referred to a clinically indicated 18F-PSMA-1007 PET-CT scan at Skåne University Hospital, Lund or Malmö, Sweden

Критерии исключения

  • Patients under 20 years old

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 2 центра
  • Skåne University Hospital — Lund
  • Skåne university hospital — Malmö

Идентификаторы

NCT: NCT06363435 · #2022-01302-02-PSMA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗