Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy
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.
Other: 18F-Fluorodeoxyglucose (18F-FDG)
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Study to See if a New Type of Imaging Can Help Our Understanding of the Course of Non-small Cell Lung Cancer in Patients Undergoing Treatment With Radiotherapy or Chemoradiotherapy|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET [ Time Frame: 7 yrs ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Patients with inoperable NSCLC undergoing RT or Chemo-RT
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.
Other Name: NAPOther: 18F-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.
Other Name: FluGlucoScan Injection
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00765986
|Contact: Lai Schrader||780.432.8464||Lai.Schrader@albertahealthservices.ca|
|Cross Cancer Institute||Recruiting|
|Edmonton, Alberta, Canada|
|Principal Investigator: Dr. Cormac Small, MD|
|Sub-Investigator: Dr. A.J.B McEwan, MB|
|Principal Investigator:||Dr. Wilson Roa, MDfirstname.lastname@example.org|