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Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo-/ Radiotherapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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.


Inclusion Criteria:



- diagnosis of non-small cell lung cancer

- Patients who are scheduled for any neo-adjuvant treatment

Exclusion Criteria:

- Females who are known to be pregnant or nursing

- Patients with a history of adverse reaction to previous contrast agent administration

- Patients with known renal disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

-Analysis will be performed to yield quantitative, absolute estimates of blood volume, blood flow, and microvascular permeability.

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Heidi C Roberts, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto

Authority:

Canada: Health Canada

Study ID:

03-0420-CE

NCT ID:

NCT00188214

Start Date:

October 2003

Completion Date:

October 2009

Related Keywords:

  • Non-Small Cell Lung Cancer
  • perfusion
  • CT
  • CAT
  • non-small
  • lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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