Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo-/ Radiotherapy
The proposed study will be performed in patients with a proven lung cancer for whom
induction therapy and subsequent surgical resection of any kind is planned. Kinetic analysis
of dynamic contrast-enhanced CT will performed using the CT Perfusion 3 software (General
Electric Medical Systems), yielding parameters characterizing tumor microvasculature in
terms of the vascularity, or the blood volume (BV), the tumor perfusion or blood flow (BF),
and the immaturity of the vascular wall, in terms of the microvascular permeability
(permeability surface area, PS).
To test the assumption that dynamic CT-assessed tumor microvascular characteristics
represent reliable, user-independent and reproducible parameters, microvascular values and
parameter maps will be derived from two independent observers. To address the interobserver
variability, each study will be analyzed by the PI and by a second researcher (blinded to
the results of the PI). Kappa-statistics will be used to assess inter-rater concordance.
To test the hypothesis that the microvascular parameters obtained from dynamic
contrast-enhanced CT predict the response to induction therapy, the parameters BV, BF and PS
obtained prior to any treatment will be correlated with the histological result from the
resected specimen (path CR or path non-CR). Spearman correlation will be used to compare
non-parametric histology results with quantitative CT microvascular parameters.
To test the hypothesis that the microvascular parameters obtained from dynamic
contrast-enhanced CT reflect the response to induction therapy, the parameters BV, BF and PS
obtained after completion of induction treatment will be correlated with the histological
result from the resected specimen (path CR or path non-CR). Spearman correlation will be
used to compare non-parametric histology results with quantitative CT microvascular
parameters.
Interventional
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
-Analysis will be performed to yield quantitative, absolute estimates of blood volume, blood flow, and microvascular permeability.
2 months
No
Heidi C Roberts, MD
Principal Investigator
University Health Network, Toronto
Canada: Health Canada
03-0420-CE
NCT00188214
October 2003
October 2009
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