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Recruiting NCT04560036

FAZA PETMRI Gastro-Oesophageal Study

No phase Interventional Metastasized Gastro-Oesophageal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FAZA PET/MRI scan.
Who it may be relevant to
Registry conditions: Metastasized Gastro-Oesophageal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Canada · 1 center
  • Univeristy Health Network — Toronto

Identifiers

NCT: NCT04560036 · 19-5849

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗