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FAZA PETMRI Gastro-Oesophageal Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04560036
Recruitment Status : Recruiting
First Posted : September 23, 2020
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Metastasized Gastro-Oesophageal Cancer Diagnostic Test: FAZA PET/MRI scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: FAZA PET/MRI scan
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Hypoxia Measurement With FAZA PET/MRI in Patients With Metastasized Gastro-Oesophageal Cancer
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Validation of FAZA PET/MRI as a biomarker of hypoxia [ Time Frame: two weeks before chemotherapy ]
    The FAZA uptake during the first PET/MRI scan

  2. Validation of FAZA PET/MRI as a biomarker of hypoxia [ Time Frame: 3 months after the chemotherapy ]
    The FAZA uptake during the 2nd PET/MRI scan


Secondary Outcome Measures :
  1. Evaluate tumour marker ctDNA in blood samples [ Time Frame: two weeks before chemotherapy ]
    Evaluate tumour marker ctDNA in blood samples

  2. Evaluate tumour marker ctDNA in blood samples [ Time Frame: 6 weeks after initiation of chemotherapy ]
    Evaluate tumour marker ctDNA in blood samples

  3. Evaluate tumour marker ctDNA in blood samples [ Time Frame: 3 months after chemotheray ]
    Evaluate tumour marker ctDNA in blood samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04560036


Contacts
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Contact: Nirushini Sivasothy 416-946-4501 ext 5773 nirushini.sivasothy@uhn.ca

Locations
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Canada, Ontario
Univeristy Health Network Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Nirushini Sivasothy    416-946-4501 ext 5773    nirushini.sivasothy@uhn.ca   
Principal Investigator: Patrick Veit-Haiback, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Patrick Veit-Haibach, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT04560036    
Other Study ID Numbers: 19-5849
First Posted: September 23, 2020    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes