Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04560036

FAZA PETMRI Gastro-Oesophageal Study

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy Health Network

Toronto, Ontario, M5G 2N2, Canada

Location status: Recruiting

Location contact

Nirushini Sivasothy

CONTACT

[email protected]

416-946-4501 ext. 5773

Patrick Veit-Haiback, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAZA PET/MRI scan

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Evaluate tumour marker ctDNA in blood samples

    Time frame: two weeks before chemotherapy

    Evaluate tumour marker ctDNA in blood samples

  2. Evaluate tumour marker ctDNA in blood samples

    Time frame: 6 weeks after initiation of chemotherapy

    Evaluate tumour marker ctDNA in blood samples

  3. Evaluate tumour marker ctDNA in blood samples

    Time frame: 3 months after chemotheray

    Evaluate tumour marker ctDNA in blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Nirushini Sivasothy

CONTACT

[email protected]

416-946-4501 ext. 5773

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 23, 2020
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.