Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2020-09-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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FAZA PET/MRI scan
FAZA PET/MRI scan before and after the standard of care chemotherapy
FAZA PET/MRI scan
FAZA PET/MRI scan before and after the standard of care chemotherapy
Interventions
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FAZA PET/MRI scan
FAZA PET/MRI scan before and after the standard of care chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Patients with de novo or secondary metastasized gastro-oesophagesal cancer (adenocarcinoma)
* Glomerular Filtration rate\> 45 ml/min
* No allergy to contrast agents
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Patrick Veit-Haibach, MD
Role: PRINCIPAL_INVESTIGATOR
University Health Network, Toronto
Locations
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Univeristy Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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19-5849
Identifier Type: -
Identifier Source: org_study_id
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