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Clinical Trials/NCT02701699
NCT02701699
Active, not recruiting
Not Applicable

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

University Health Network, Toronto1 site in 1 country36 target enrollmentDecember 1, 2014
ConditionsLung Cancer
Interventions18-F-FAZA

Overview

Phase
Not Applicable
Intervention
18-F-FAZA
Conditions
Lung Cancer
Sponsor
University Health Network, Toronto
Enrollment
36
Locations
1
Primary Endpoint
Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy
Status
Active, not recruiting
Last Updated
last month

Overview

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

Registry
clinicaltrials.gov
Start Date
December 1, 2014
End Date
June 1, 2027
Last Updated
last month
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • Age less than 18 years old
  • Failure to provide written informed consent

Arms & Interventions

18-F-FAZA Scan

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

Intervention: 18-F-FAZA

Outcomes

Primary Outcomes

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

Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake

Time Frame: 5 years

Secondary Outcomes

  • Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy(5 years)

Study Sites (1)

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