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临床试验/NCT04560036
NCT04560036招募中不适用

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

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
2
主要终点
Validation of FAZA PET/MRI as a biomarker of hypoxia

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Contraindication for MR as per current institutional guidelines
  • Inability to lie supine for at least 30 minutes
  • Any patient who is pregnant or breastfeeding
  • Any patient unable or unwilling to provide informed consent
  • Patients who are allergic to ethanol as the FAZA preparation contains ethanol

研究组 & 干预措施

FAZA PET/MRI scan

Other

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

干预措施: FAZA PET/MRI scan (Diagnostic Test)

结局指标

主要结局

Validation of FAZA PET/MRI as a biomarker of hypoxia

时间窗: 3 months after the chemotherapy

The FAZA uptake during the 2nd PET/MRI scan

次要结局

  • Evaluate tumour marker ctDNA in blood samples(3 months after chemotheray)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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