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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02701699
• Other study ID #: UHN REB 13-6528-C
• Status: Recruiting
• Phase: N/A
• Start date: December 2014
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: University Health Network, Toronto
• Contact: Alex Sun, MD
• Phone: 416 946 4501
• Email: Alex.Sun[@]rmp.uhn.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Biological:
• 18-F-FAZA
All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with lung cancer using the PET tracer FAZA to image primary tumor hypoxia prior to treatment with radiotherapy		5 years
Primary	Number of patients with lung cancer using 4D (gated) and static PET imaging of FAZA uptake		5 years
Secondary	Proportion of the volume of injected FAZA tracer taken up in the tumor prior to treatment with radiotherapy		5 years