Univeristy Health Network
Toronto, Ontario, M5G 2N2, Canada
Location status: Recruiting
NCT Number: NCT04560036
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Toronto, Ontario, M5G 2N2, Canada
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
FAZA PET/MRI scan before and after the standard of care chemotherapy
Time frame: two weeks before chemotherapy
The FAZA uptake during the first PET/MRI scan
Time frame: 3 months after the chemotherapy
The FAZA uptake during the 2nd PET/MRI scan
Time frame: two weeks before chemotherapy
Evaluate tumour marker ctDNA in blood samples
Time frame: 6 weeks after initiation of chemotherapy
Evaluate tumour marker ctDNA in blood samples
Time frame: 3 months after chemotheray
Evaluate tumour marker ctDNA in blood samples
Contact information is provided by the study sponsor or research team.
University Health Network, Toronto
Other
Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
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