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FAZA PETMRI Gastro-Oesophageal Study

Primary Purpose

Metastasized Gastro-Oesophageal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
FAZA PET/MRI scan
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastasized Gastro-Oesophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Univeristy Health NetworkRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FAZA PET/MRI scan

Arm Description

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

Outcomes

Primary Outcome Measures

Validation of FAZA PET/MRI as a biomarker of hypoxia
The FAZA uptake during the first PET/MRI scan
Validation of FAZA PET/MRI as a biomarker of hypoxia
The FAZA uptake during the 2nd PET/MRI scan

Secondary Outcome Measures

Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples
Evaluate tumour marker ctDNA in blood samples

Full Information

First Posted
September 11, 2020
Last Updated
May 12, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT04560036
Brief Title
FAZA PETMRI Gastro-Oesophageal Study
Official Title
Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasized Gastro-Oesophageal Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
FAZA PET/MRI scan
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FAZA PET/MRI scan
Arm Type
Other
Arm Description
FAZA PET/MRI scan before and after the standard of care chemotherapy
Intervention Type
Diagnostic Test
Intervention Name(s)
FAZA PET/MRI scan
Intervention Description
FAZA PET/MRI scan before and after the standard of care chemotherapy
Primary Outcome Measure Information:
Title
Validation of FAZA PET/MRI as a biomarker of hypoxia
Description
The FAZA uptake during the first PET/MRI scan
Time Frame
two weeks before chemotherapy
Title
Validation of FAZA PET/MRI as a biomarker of hypoxia
Description
The FAZA uptake during the 2nd PET/MRI scan
Time Frame
3 months after the chemotherapy
Secondary Outcome Measure Information:
Title
Evaluate tumour marker ctDNA in blood samples
Description
Evaluate tumour marker ctDNA in blood samples
Time Frame
two weeks before chemotherapy
Title
Evaluate tumour marker ctDNA in blood samples
Description
Evaluate tumour marker ctDNA in blood samples
Time Frame
6 weeks after initiation of chemotherapy
Title
Evaluate tumour marker ctDNA in blood samples
Description
Evaluate tumour marker ctDNA in blood samples
Time Frame
3 months after chemotheray

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nirushini Sivasothy
Phone
416-946-4501
Ext
5773
Email
nirushini.sivasothy@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haibach, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nirushini Sivasothy
Phone
416-946-4501
Ext
5773
Email
nirushini.sivasothy@uhn.ca
First Name & Middle Initial & Last Name & Degree
Patrick Veit-Haiback, MD

12. IPD Sharing Statement

Learn more about this trial

FAZA PETMRI Gastro-Oesophageal Study

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