Clinical trial NCT04560036: FAZA PETMRI Gastro-Oesophageal Study
Official title: Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastasized Gastro-Oesophageal Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-09-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: FAZA PET/MRI scan
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Validation of FAZA PET/MRI as a biomarker of hypoxia
timeFrame: two weeks before chemotherapy
measure: Validation of FAZA PET/MRI as a biomarker of hypoxia
timeFrame: 3 months after the chemotherapy
Secondary outcomes:
measure: Evaluate tumour marker ctDNA in blood samples
timeFrame: two weeks before chemotherapy
measure: Evaluate tumour marker ctDNA in blood samples
timeFrame: 6 weeks after initiation of chemotherapy
measure: Evaluate tumour marker ctDNA in blood samples
timeFrame: 3 months after chemotheray
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Univeristy Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Patrick Veit-Haibach, MD
role: PRINCIPAL_INVESTIGATOR
References: