NCT04560036Recruiting
FAZA PETMRI Gastro-Oesophageal Study
Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
Source: ClinicalTrials.gov · Last updated 10 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 11 Sept 2020
- Start date
- 15 Sept 2020
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University Health Network, Toronto
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT04560036
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 Sept 2020 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who are allergic to ethanol as the FAZA preparation contains ethanol
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univeristy Health Network Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.