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

Study Overview
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Brief Summary
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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

Official Title
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A Feasibility Study of Hypoxia Imaging in Patients With Lung Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: 18-F-FAZA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years 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 Intention to treat using radiotherapy according to the current treatment policies of the PMH Lung Group Concurrent systemic therapy allowed A negative serum pregnancy test within the two week interval immediately prior to PET-CT imaging, in women of child-bearing age Ability to provide written informed consent to participate in the study Exclusion Criteria: Previous radiotherapy to intended treatment volumes. Previous systemic therapy Active malignancy other than lung cancer Unable to remain supine for more than 60 minutes Pregnancy Age less than 18 years old Failure to provide written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18-F-FAZA Scan<br>All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction | Biological: 18-F-FAZA<br>* All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy |  | 5 years | 
| Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Cancer, FAZA PET Imaging, Lung Radiotherapy