Recruiting

FAZA PETMRI

Sponsor:

University Health Network, Toronto

Code:

NCT04560036

Conditions

Metastasized Gastro-Oesophageal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

FAZA PET/MRI scan

Study Details

Brief 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.

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.

Conditions

Metastasized Gastro-Oesophageal Cancer

Study ID

NCT04560036

Start date

Sep 15, 2020

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: FAZA PET/MRI scan

FAZA PET/MRI scan before and after the standard of care chemotherapy

Interventions

FAZA PET/MRI scan

FAZA PET/MRI scan before and after the standard of care chemotherapy

Primary outcome measure

  • Validation of FAZA PET/MRI as a biomarker of hypoxia [ Time Frame: two weeks before chemotherapy ]
  • Validation of FAZA PET/MRI as a biomarker of hypoxia [ Time Frame: 3 months after the chemotherapy ]

Central Contacts and Locations

Central contacts

Locations

Univeristy Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contacts

Principal Investigator:

Patrick Veit-Haiback, MD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-10.