RecruitingNot ApplicableNCT04560036

FAZA PETMRI Gastro-Oesophageal Study

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


Sponsor

University Health Network, Toronto

Enrollment

40 participants

Start Date

Sep 15, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This imaging study uses a special PET/MRI scan with a tracer called FAZA to measure oxygen levels in tumors in patients with stomach or esophageal cancer that has spread. Understanding tumor oxygen levels may help predict how well treatments will work. **You may be eligible if...** - You are 18 or older - You have been diagnosed with gastric or esophageal cancer (adenocarcinoma type) that has spread (metastatic) - Your kidneys are functioning adequately - You have no allergy to contrast agents used in MRI scans **You may NOT be eligible if...** - You have a condition that prevents you from safely having an MRI scan - You cannot lie flat on your back for at least 30 minutes - You are pregnant or breastfeeding - You are allergic to ethanol (alcohol), as the FAZA imaging agent contains ethanol - You are unwilling or unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTFAZA PET/MRI scan

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


Locations(1)

Univeristy Health Network

Toronto, Ontario, Canada

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NCT04560036