Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy
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|ClinicalTrials.gov Identifier: NCT00765986|
Recruitment Status : Unknown
Verified October 2014 by AHS Cancer Control Alberta.
Recruitment status was: Recruiting
First Posted : October 3, 2008
Last Update Posted : October 3, 2014
|Condition or disease||Intervention/treatment|
|Lung Neoplasm Cell Hypoxia||Other: 18F-FAZA Other: 18F-Fluorodeoxyglucose (18F-FDG)|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||October 2015|
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: NAP
Other: 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
- 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 ]
- 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 ]
- To assess if patterns of local failure/overall survival correlate with 18F-FAZA PET and/or FluGlucoScan Injection PET [ Time Frame: 7 yrs ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, MDemail@example.com|