Идёт набор NCT04560036

FAZA PETMRI Gastro-Oesophageal Study

Без фазы С лечением Metastasized Gastro-Oesophageal 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: FAZA PET/MRI scan.
Кому может быть актуально: Состояния в реестре: Metastasized Gastro-Oesophageal 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: Канада
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

Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer

Обзор

This is a single arm, pilot study of PET/MRI scan with radiotracer 18F-Fluoroazomycin Arabinoside (FAZA) before and after standard of care platinum-based chemotherapy for patients with metastasized Gastro-Oesophageal Cancer. Gastroesophageal cancer (GEC) accounted for 2,3000 deaths in Canada in 2017 and majority of the patients present or develop metastatic disease following diagnosis. These patients are treated with platinum-based chemotherapy. There is currently no biomarker that can be used to predict the therapy responses. Additionally, patients that do not respond to the chemotherapy often deteriorate rapidly and are unable to receive second line therapy. Intratumoral hypoxia (low oxygen concentration) is a signature feature of aggressive and resistant tumour phenotype. Accurately predicting hypoxia in solid tumours offers an innovative and rational pradigm for predicting therapy responses. PET/MRI is an imaging technique combining the Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. A radiotracer called 18F-Fluoroazomycin Arabinoside (FAZA) is used as a type of "dye" in the PET/MRI scan. The primary goal of the study is to validate FAZA PET/MRI as a biomarker of hyupoxia in setting of gastro-oesophageal carcinoma. Patients with GEC will undergo FAZA PET/MRI scan before and after the standard of care chemotherapy. This would be correlated with clinical outcome in patients with metastatic GEC that have different responses to chemotherapy. Ultimately, we hope that the use FAZA PET/MRI in the study can help select the most effective treatment method for advanced GEC to extend life and improve quality of life while minimizing toxicity and healthcare costs. The study subjects' clinical management will not be changed based on the PET-MR scan within the trial.

Вмешательства

Диагностический тест FAZA PET/MRI scan
FAZA PET/MRI scan before and after the standard of care chemotherapy

Первичные конечные точки

Validation of FAZA PET/MRI as a biomarker of hypoxia [Срок оценки: two weeks before chemotherapy]
Validation of FAZA PET/MRI as a biomarker of hypoxia [Срок оценки: 3 months after the chemotherapy]

Вторичные конечные точки (3)

Evaluate tumour marker ctDNA in blood samples [Срок оценки: two weeks before chemotherapy]
Evaluate tumour marker ctDNA in blood samples [Срок оценки: 6 weeks after initiation of chemotherapy]
Evaluate tumour marker ctDNA in blood samples [Срок оценки: 3 months after chemotheray]

Критерии участия

Критерии включения

Age ≥18 years
Patients with de novo or secondary metastasized gastro-oesophagesal cancer (adenocarcinoma)
Glomerular Filtration rate> 45 ml/min
No allergy to contrast agents