Metastasized Gastro-Oesophageal CancerNCT04560036
FAZA PETMRI Gastro-Oesophageal Study
A study testing FAZA PET/MRI scan in people with Metastasized Gastro-Oesophageal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastasized Gastro-Oesophageal Cancer
- What is being tested?
- FAZA PET/MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2020to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients who are allergic to ethanol as the FAZA preparation contains ethanol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Univeristy Health Network
Toronto, Ontario, M5G 2N2
Nirushini Sivasothy, 416-946-4501 ext. 5773, nirushini.sivasothy@uhn.ca
Patrick Veit-Haiback, MD
About this study
Official title: Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
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.
Read more
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.
- Conditions
- Metastasized Gastro-Oesophageal Cancer
- Being tested
- FAZA PET/MRI scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAZA PET/MRI scanDiagnostic test
FAZA PET/MRI scan before and after the standard of care chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| FAZA PET/MRI scan | Other | FAZA PET/MRI scan before and after the standard of care chemotherapy Receives: Diagnostic Test: FAZA PET/MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of FAZA PET/MRI as a biomarker of hypoxia
The FAZA uptake during the first PET/MRI scan
Measured: two weeks before chemotherapy
Validation of FAZA PET/MRI as a biomarker of hypoxia
The FAZA uptake during the 2nd PET/MRI scan
Measured: 3 months after the chemotherapy
Secondary outcomes (3)
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Measured: two weeks before chemotherapy
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Measured: 6 weeks after initiation of chemotherapy
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Measured: 3 months after chemotheray
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Sep 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastasized Gastro-Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- FAZA PET/MRI scan
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560036
- Sponsor's protocol ID
- 19-5849
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No