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Status unknownNCT00765986Updated Oct 3, 2014

Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy

An observational study in Lung Neoplasm and Cell Hypoxia, sponsored by AHS Cancer Control Alberta. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-03.

Sponsored by AHS Cancer Control Alberta · Observational

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study summary

Non-small cell lung cancer (NSCLC) has a poor prognosis if not caught early enough. One of the factors that may impact the ability to control NSCLC is low oxygen levels (hypoxia) inside the tumour. This study will use 18F-FAZA PET scans to assess whether patients have hypoxic tumours and to monitor the changes to the hypoxic areas of a tumour during currently available standard treatment. It is hypothesized that 18F-FAZA PET may predict response to treatment, local control, and/or survival in NSCLC.

Read the detailed description

Locally advanced NSCLC has a poor prognosis with a 5 year overall survival rate of only 15%. Tumour hypoxia may impact the ability to control NSCLC. Using 18F-FAZA PET, this study will assess patients for hypoxic treatment. With this information, we can start individualizing patient treatment to target hypoxia. The relationship between areas of hypoxia (18F-FAZA) and high glucose utilization (18F-FDG) will also be assessed.

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Conditions studied

  • Lung Neoplasm
  • Cell Hypoxia

Keywords

  • 18F-FAZA
  • 18F-FDG
  • Positron Emission Tomography
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 30 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

AHS Cancer Control Alberta is the lead sponsor of 182 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with inoperable NSCLC undergoing radiotherapy or chemoradiotherapy

Inclusion criteria

  1. Patients with histologically-proven, by biopsy or cytology, unresected lung cancer of the following histological types: squamous cell carcinoma; adenocarcinoma; undifferentiated large cell carcinoma, and non-small cell, not otherwise specified (NOS, diagnosis on cytology alone)
  2. Patients with American Joint Committee on Cancer (AJCC) Stage I, II, IIIA, or IIIB with detectable tumour that can be encompassed by radiation therapy fields, including both primary tumour and the involved regional lymph nodes.
  3. Patients must be deemed to be suitable to undergo definitive (i.e. potentially curable) chemoradiotherapy or radiotherapy by the treating Physician.
  4. The prescribed radiotherapy dose must be a minimum of 60 Gy in 30 fractions
  5. Male or female ≥ 18 years of age. If female of child bearing potential and outside the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
  6. ECOG/Zubrod status 0-1
  7. Patients must have at least one measurable lesion ≥ 1 cm on CT
  8. Able and willing to follow instructions and comply with the protocol
  9. Provide written informed consent prior to participation in the study

Exclusion criteria

Exclusion Criteria:

  1. Patients who have undergone complete or subtotal tumour resection
  2. Patients with post-resection intrathoracic tumour recurrence
  3. Patients eligible for definitive surgery (patients who are eligible for surgery, but surgery did not proceed are eligible for this trial)
  4. No distant or metastasis, prior chemotherapy, or thoracic neck or radiotherapy
  5. Evidence of any small cell histology
  6. Prior or concurrent malignancy (except non-melanomatous skin cancer) unless disease-free for at least 5 years
  7. Inability to lay in supine position for approximately one hour
  8. Nursing or pregnant females
  9. Aged less than 18 years
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)

Groups and cohorts

  • 1

    Patients with inoperable NSCLC undergoing RT or Chemo-RT

    Other: 18F-FAZA · Other: 18F-Fluorodeoxyglucose (18F-FDG)

Interventions

  • Other18F-FAZA

    Radioactive dose of 110-600 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) of RT, then 4 weeks, 90 days and 12 months post-RT and upon logo-regional progression or recurrence.

    Also known as: NAP

  • Other18F-Fluorodeoxyglucose (18F-FDG)

    Radioactive dose of 100-710 MBq per injection. Up to a maximum of 6 injections per patient: pre-Tx, after 4 weeks (20 fractions) RT, then 4 weeks, 90 days, and 12 months post-RT, and upon loco-regional progression or recurrence.

    Also known as: FluGlucoScan Injection

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What researchers measure

Primary outcomes

  1. To determine the relationship between hypoxic changes and the early local tumour response after definitive radiotherapy or chemoradiotherapy in NSCLC

    Time frame: 2.5 yrs

Secondary outcomes

  1. To establish if a correlation exists between 18F-FAZA PET and FluGlucoScan Injection PET in determining responses to definitive treatment in NSCLC

    Time frame: 2.5 yrs

  2. To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET

    Time frame: 7 yrs

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Study locations

1 of 1 sites recruiting
  • Cross Cancer Institute
    Edmonton, Alberta, Canada
    • Dr. Cormac Small, MD · Principal investigator
    • Dr. A.J.B McEwan, MB · Sub investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00765986
Lead sponsor
AHS Cancer Control Alberta
Responsible party
Sponsor
First posted
Oct 3, 2008
Start date
Oct 2008
Primary completion
Sep 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Oct 3, 2014

Study contacts

Lai Schrader
Contact
Lai.Schrader@albertahealthservices.ca
780.432.8464
Dr. Wilson Roa, MD
principal investigator · wilson.roa@albertahealthservices.ca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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