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

NCT02701699 | Active Not Recruiting

• 1 other identifier: 13-6528
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

Lung Cancer; FAZA PET Imaging; Lung Radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  5 years

Study Arms (1)

18-F-FAZA Scan

EXPERIMENTAL

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

Biological: 18-F-FAZA

Interventions

18-F-FAZA BIOLOGICAL

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

18-F-FAZA Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Alex Sun, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: March 8, 2016
• Study Start: December 1, 2014
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

CA (1)