Идёт набор NCT06232889

Deuterium Metabolic MRI and [18F]FDG PET for Assessment of Treatment Response Following Radioembolization

Без фазы С лечением Fluorodeoxyglucose F18 Phosphoric Monoester Hydrolases Phosphoric Diester Hydrolases

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: Deuterium Glucose Metabolic Imaging with MRI spectroscopy.
Кому может быть актуально: Состояния в реестре: Fluorodeoxyglucose F18, Phosphoric Monoester Hydrolases, Phosphoric Diester Hydrolases. 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: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Deuterium Metabolic MRI and [18F]-Flourodesoxyglucose Positron Emission Tomography for Assessment of Treatment Response Following Radioembolization; Pilot Study

Обзор

Radioembolization, also known as Selective Internal Radiation Therapy (SIRT), is a liver-directed therapy for patients suffering from hepatic metastases. As SIRT is a liver-directed treatment, only patients with liver-only or liver-dominant disease are eligible for treatment. FDG-PET/CT is known to outperform conventional anatomical imaging modalities (CT or MRI) for treatment response assessment, also being of prognostic value. Subsequently following SIRT, patients are restaged with FDG-PET/CT. However, optimal timing of restaging following treatment is unknown (most commonly after 1 or 3 months, according to local institutional guidelines). More importantly, intrinsic resolution of FDG-PET/CT limits its utility in patients with small metastases, as image quality is worsened by high background noise, due to physiologic FDG uptake / metabolism in normal liver parenchyma. Additionally, FDG as radiopharmaceutical increases additional radiation burden to patients. This study will investigate the potential of metabolic MRI (7T MRI), non-invasively imaging metabolites using X-nuclei (e.g. 31P MRSI) and more importantly, the application of Deuterium Metabolic Imaging (DMI) with non-radioactive deuterated glucose, as a potential alternative over FDG-PET/CT.

Вмешательства

Диагностический тест Deuterium Glucose Metabolic Imaging with MRI spectroscopy
MRI spectroscopy of the liver, following ingestion of 20 mg deuterium glucose p.o., prior to and after radioembolization treatment for mCRC

Первичные конечные точки

To confirm feasibility of DMI for intrahepatic tumor detection. [Срок оценки: 1 and 3 months after radioembolization, anatomical and molecular imaging is repeated.]

Критерии участия

Критерии включения

Adults (≥18 years)
Referred for SIRT and deemed eligible by the multidisciplinary tumor board
Size of at least one liver metastasis ≥ 1 cm on contrast enhanced CT / MRI (measurable according to RECIST 1.1) and 18FDG-avid metastatic liver disease (uptake > healthy liver uptake; measurable according to PERCIST)
Written informed consent