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

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
18-F-FAZA
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung Cancer, FAZA PET Imaging, Lung Radiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18-F-FAZA Scan

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy
Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake

Secondary Outcome Measures

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

Full Information

First Posted
December 9, 2014
Last Updated
April 5, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02701699
Brief Title
18F-Fluoroazomycin Arabinoside (18F-FAZA) in Lung Cancer
Official Title
A Feasibility Study of Hypoxia Imaging in Patients With Lung Cancer Using Positron Emission Tomography (PET) With 18F-Fluoroazomycin Arabinoside (18F-FAZA)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer, FAZA PET Imaging, Lung Radiotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18-F-FAZA Scan
Arm Type
Experimental
Arm Description
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
Intervention Type
Biological
Intervention Name(s)
18-F-FAZA
Intervention Description
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
Primary Outcome Measure Information:
Title
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
Title
Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Pregnancy Age less than 18 years old Failure to provide written informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Sun, MD
Phone
416 946 4501
Ext
2126
Email
Alex.Sun@rmp.uhn.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Breen, PhD
Phone
416 946 4501
Ext
5812
Email
Stephen.Breen@rmp.uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Sun, MD
Organizational Affiliation
The Princess Margaret Cancer Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex Sun, MD
Phone
416 946 4501
Ext
2126
Email
Alex.Sun@rmp.uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Stephen Breen, PhD
Phone
416 946 4501
Ext
5812
Email
Stephen.Breen@rmp.uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Alex Sun, MD

12. IPD Sharing Statement

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

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