FAZA PET/MRI Scan for Gastroesophageal Cancer
Trial Summary
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications, as the study focuses on imaging and does not change your clinical management.
What data supports the effectiveness of the drug 18F-Fluoroazomycin Arabinoside (FAZA) for gastroesophageal cancer?
Research shows that FAZA is effective in identifying low-oxygen areas in tumors, which is important for understanding how well a tumor might respond to treatments like radiation. While this has been studied in other cancers, such as head and neck cancer, it suggests potential usefulness in gastroesophageal cancer as well.12345
Is the FAZA PET/MRI scan safe for humans?
The studies on 18F-Fluoroazomycin Arabinoside (FAZA) primarily focus on its use as a PET tracer for identifying low-oxygen areas in tumors, and they do not report any specific safety concerns for humans. However, these studies do not provide detailed safety data, so it's important to discuss potential risks with your healthcare provider.12367
How does the FAZA PET/MRI scan treatment for gastroesophageal cancer differ from other treatments?
The FAZA PET/MRI scan is unique because it uses a special tracer, (18)F-fluoroazomycin arabinoside (FAZA), to identify low-oxygen areas within tumors, which can be crucial for understanding tumor behavior and planning treatment. This approach is different from standard treatments as it provides detailed imaging of tumor hypoxia, which is not typically assessed in routine cancer treatments.12356
Research Team
Patrick Veit-Haibach, MD
Principal Investigator
University Health Network, Toronto
Eligibility Criteria
This trial is for adults over 18 with advanced gastroesophageal cancer who can lie down for at least 30 minutes and have a kidney function test (GFR) above 45 ml/min. It's not suitable for those allergic to contrast agents, pregnant or breastfeeding women, anyone unable to consent, or those with allergies to ethanol.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment Imaging
Participants undergo FAZA PET/MRI scan to measure hypoxia before chemotherapy
Treatment
Participants receive standard of care platinum-based chemotherapy
Post-treatment Imaging
Participants undergo FAZA PET/MRI scan to measure hypoxia after chemotherapy
Follow-up
Participants are monitored for clinical outcomes and tumor marker ctDNA in blood samples
Treatment Details
Interventions
- 18F-Fluoroazomycin Arabinoside (FAZA)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor