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

NCT ID: NCT02701699

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2025-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18-F-FAZA Scan

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

Group Type EXPERIMENTAL

18-F-FAZA

Intervention Type BIOLOGICAL

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

Interventions

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18-F-FAZA

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Sun, MD

Role: PRINCIPAL_INVESTIGATOR

The Princess Margaret Cancer Foundation

Locations

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University Health Network, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Alex Sun, MD

Role: CONTACT

416 946 4501 ext. 2126

Stephen Breen, PhD

Role: CONTACT

416 946 4501 ext. 5812

Facility Contacts

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Alex Sun, MD

Role: primary

416 946 4501 ext. 2126

Stephen Breen, PhD

Role: backup

416 946 4501 ext. 5812

Other Identifiers

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UHN REB 13-6528-C

Identifier Type: -

Identifier Source: org_study_id

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