FAZA PETMRI Gastro-Oesophageal Study

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.

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 Overview

• Status: Recruiting
• Conditions: Metastasized Gastro-Oesophageal Cancer
• Intervention / Treatment: Diagnostic test: FAZA PET/MRI scan

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nirushini Sivasothy; Phone Number: 5773 416-946-4501; Email: nirushini.sivasothy@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2N2
      • Recruiting
      • Univeristy Health Network
      • Principal Investigator: Patrick Veit-Haiback, MD
      • Contact: Nirushini Sivasothy; Phone Number: 5773 416-946-4501; Email: nirushini.sivasothy@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FAZA PET/MRI scan; FAZA PET/MRI scan before and after the standard of care chemotherapy	Diagnostic test: FAZA PET/MRI scan; FAZA PET/MRI scan before and after the standard of care chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of FAZA PET/MRI as a biomarker of hypoxia	The FAZA uptake during the first PET/MRI scan	two weeks before chemotherapy
Validation of FAZA PET/MRI as a biomarker of hypoxia	The FAZA uptake during the 2nd PET/MRI scan	3 months after the chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate tumour marker ctDNA in blood samples	Evaluate tumour marker ctDNA in blood samples	two weeks before chemotherapy
Evaluate tumour marker ctDNA in blood samples	Evaluate tumour marker ctDNA in blood samples	6 weeks after initiation of chemotherapy
Evaluate tumour marker ctDNA in blood samples	Evaluate tumour marker ctDNA in blood samples	3 months after chemotheray

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Patrick Veit-Haibach, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 11, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 19-5849

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No