FAZA PETMRI Gastro-Oesophageal Study | NCT04560036

Studies
FAZA PETMRI Gastro-Oesophageal Study

NCT04560036

Sponsor

University Health Network, Toronto

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Metastasized Gastro-Oesophageal Cancer

Interventions

FAZA PET/MRI scan

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Sep 11, 2020

First Submission Date that Met QC Criteria

Sep 16, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FAZA PET/MRI scan	Other	FAZA PET/MRI scan before and after the standard of care chemotherapy	Diagnostic Test: FAZA PET/MRI scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FAZA PET/MRI scan	Diagnostic Test	FAZA PET/MRI scan before and after the standard of care chemotherapy	FAZA PET/MRI scan

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nirushini Sivasothy	Contact	416-946-4501	5773	nirushini.sivasothy@uhn.ca

Overall Officials

Name	Affiliation	Role
Patrick Veit-Haibach, MD	University Health Network, Toronto	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Univeristy Health Network	Recruiting	Toronto	Ontario	M5G 2N2	Canada