A Phase II Pre-Treatment Hypoxia PET Imaging Study Using 18F-FAZA in Patients With Invasive Duct Carcinoma of the Breast
Hypoxia or anoxia can be found in 50% of locally advanced breast carcinomas. Assessment of
pre-treatment in viva and in vitro hypoxia could allow patient selection for more aggressive
therapy or clinical trails focused on targeting hypoxia. We will use the PET radiotracer
18F-FAZA to monitor hypoxia in the protocol. We will study pathological characteristics on
the final tumour restriction specimen and correlate prognostic and predictive factors with
PET scan data. Tumour banking is optional.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Uptake of 18F-FAZA (RUS and T/B) and its correlation to tumour size, auxiliary nodal status, tumour grade, EP/PR, and HER-2 status, Ki-67, Androgen receptor status (AR), vimentin and basal keratins, HIF-1 a and glomeruloid microvascular proliferation.
5 years
No
Alexander J.B. McEwan, MB,BS,MSc
Principal Investigator
Cross Cancer Institute
Canada: Health Canada
BR-24334/KT-FAZ-004
NCT00771381
November 2008
June 2013
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