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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
- ClinicalTrials.gov ID
- NCT04560036
- Acronym / sponsor ID
- 19-5849
- Conditions
- Metastasized Gastro-Oesophageal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- FAZA PET/MRI scan
| Arm | Type | Receives |
|---|---|---|
| FAZA PET/MRI scan | Other | Diagnostic Test: FAZA PET/MRI scanFAZA PET/MRI scan before and after the standard of care chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAZA PET/MRI scanFAZA PET/MRI scan before and after the standard of care chemotherapy | Diagnostic test | FAZA PET/MRI scan |
Primary outcome
Validation of FAZA PET/MRI as a biomarker of hypoxia
Time frame: two weeks before chemotherapy
The FAZA uptake during the first PET/MRI scan
Validation of FAZA PET/MRI as a biomarker of hypoxia
Time frame: 3 months after the chemotherapy
The FAZA uptake during the 2nd PET/MRI scan
3 secondary outcomes
Evaluate tumour marker ctDNA in blood samples
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nirushini Sivasothy (416-946-4501 ext. 5773, nirushini.sivasothy@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of FAZA PET/MRI as a biomarker of hypoxia (time frame: two weeks before chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.