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18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung Cancer

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ClinicalTrials.gov Identifier: NCT02701699
Recruitment Status : Recruiting
First Posted : March 8, 2016
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief Summary:

The purpose of this study is to look for low levels of oxygen (hypoxia) in lung cancer using a positron emission tomography (PET) scan. Hypoxia can influence how lung cancer grows and responds to treatments like radiotherapy and chemotherapy. The use of PET scans to measure hypoxia may be better and simpler than the approaches used previously. This study will assess whether or not PET scans can provide useful information about hypoxia in lung cancer.

In this study, a radiotracer called Fluoroazomycin Arabinoside (FAZA) will be used to measure hypoxia in the patient's tumour. FAZA has already been used in many cancers including lung cancer. Patients who consent to participate in this trial will receive 1 FAZA PET Scan prior to their first radiotherapy treatment


Condition or disease Intervention/treatment Phase
Lung Cancer Biological: 18-F-FAZA Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Feasibility Study of Hypoxia Imaging in Patients With Lung Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Actual Study Start Date : December 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 18-F-FAZA Scan
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
 Biological: 18-F-FAZA
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy [ Time Frame: 5 years ]
  2. Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy [ Time Frame: 5 years ]

Eligibility Criteria
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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:

  1. Age ≥ 18 years
  2. Patients with stage II or III lung cancer (both NSCLC and SCLC) qualifying for radiotherapy to the primary tumor, with or without treatment of mediastinal or hilar lymph nodes
  3. Intention to treat using radiotherapy according to the current treatment policies of the PMH Lung Group
  4. Concurrent systemic therapy allowed
  5. A negative serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age
  6. Ability to provide written informed consent to participate in the study

Exclusion Criteria:

  1. Previous radiotherapy to intended treatment volumes.
  2. Previous systemic therapy
  3. Active malignancy other than lung cancer
  4. Unable to remain supine for more than 60 minutes
  5. Pregnancy
  6. Age less than 18 years old
  7. Failure to provide written informed consent
Contacts and Locations
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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): NCT02701699


Contacts
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Contact: Alex Sun, MD 416 946 4501 ext 2126 Alex.Sun@rmp.uhn.on.ca
Contact: Stephen Breen, PhD 416 946 4501 ext 5812 Stephen.Breen@rmp.uhn.on.ca

Locations
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Canada, Ontario
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Alex Sun, MD    416 946 4501 ext 2126    Alex.Sun@rmp.uhn.on.ca   
Contact: Stephen Breen, PhD    416 946 4501 ext 5812    Stephen.Breen@rmp.uhn.on.ca   
Principal Investigator: Alex Sun, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Alex Sun, MD University Health Network--Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02701699    
Other Study ID Numbers: UHN REB 13-6528-C
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Keywords provided by University Health Network, Toronto:
Lung Cancer
FAZA PET Imaging
Lung Radiotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Fluoroazomycin arabinoside
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action