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NCT Number: NCT02701699

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18-F-FAZA

Biological

All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction

Primary outcomes

  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 outcomes

  1. Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: FAZA Lung

Important dates

Study start
2014
Primary completion
2027
Study completion
2027
First posted
Mar 8, 2016
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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