Меню
Идёт набор NCT06526442

MRE for Diagnosis of Pancreatic Masses

— Наблюдательное Pancreatic Neoplasm Magnetic Resonance Imaging

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: magnetic resonance imaging.
Кому может быть актуально
Состояния в реестре: Pancreatic Neoplasm, Magnetic Resonance Imaging. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Experimental and Clinical Study of Three-dimensional Magnetic Resonance Elastography to Evaluate Pancreatic Cancer and Interstitial Fibrosis

Обзор

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials. The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Подробное описание

Pancreatic ductal adenocarcinoma (PDAC) accounts for 85-95% of pancreatic cancer and is one of the deadliest tumors in the world, with a survival rate of less than 8%, and identifying key prognostic or predictive factors facilitates risk stratification and prospective assessment in clinical trials.

The extracellular matrix (ECM) surrounding PDAC often exhibits a large number of interstitial fibrosis, which is closely related to the formation, development and metastasis of PDAC. Although interstitial composition is considered a double-edged sword, influencing cancer biological progression and modification in multiple complex ways, experimental studies consistently demonstrate that hardening of ECM in PDAC accelerates PDAC progression and is significantly associated with shorter survival. If investigators can noninvasively detect the mechanical properties (hardness) of human PDAC before treatment, it will be helpful to describe the biological characteristics of tumors, predict the prognosis of patients, and choose the right clinical treatment decision.

High order three-dimensional MR elastography (3D-MRE) allows non-invasive measurements of sheer stiffness in normal pancreas and pancreatic lesions. However, there are no reports about the application of MRE imaging biomarkers to predict the prognosis of PDAC at home and abroad.

Вмешательства

  • Диагностический тест magnetic resonance imaging
    all participants undergo novel MR sequences, including 3D-MRE，DCE-MRI，IVIM-DWI，T1/T2 mapping.

Первичные конечные точки

  • Analyzing the measurement accuracy of MRE. [Срок оценки: 9 months]
  • Radiological assessment of tumor stiffness. [Срок оценки: 9 months]
  • Evaluation of tumor response to chemotherapy. [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • granting of written informed consent
  • age ≥18 years
  • no history of extrapancreatic malignancy
  • no preoperative biliary drainage
  • definitive histologic evidence of PDAC in excisional biopsy
  • with no less than three months of postoperative mortality or six months of follow- up

Критерии исключения

  • inability to re-review of tissue specimens
  • unacceptable estimates of MRE parameters, specifically invalid wave data during postprocessing, inconsistent breath-holdings, intolerable pain, and MRE hardware disconnection
  • tumor diameters <1.0 cm
  • withdrawal/dropout during follow-up

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Shengjing hospital of china medical university — Шэньян

Публикации

  • Yang A, Gu C, Liu Y, Luo B, Zeng Y, Zhou M, Li C, Pan C, Wu L, Hu Z, Zhang X, Gao F, Shi Y. ITGB5-mediated biomechanical regulation in pancreatic ductal adenocarcinoma stroma impacts tumor progression and prognosis. J Transl Med. 2025 Oct 21;23(1):1150. doi: 10.1186/s12967-025-07119-5. PMID 41121153

Идентификаторы

NCT: NCT06526442 · SJ-16001-MRE

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗