Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00188214
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2005-09-09
Brief Title:
CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo - Radiotherapy
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo- Radiotherapy
Status:
COMPLETED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cancer of the lung is treated with surgery radiation or chemotherapy depending on the stage or extent of the disease Some patients are treated with chemotherapy andor radiation therapy before surgery to improve the results of surgery After these treatments we do not know whether the residual tumour tissue is still alive or dead which is why some physicians feel that surgery is required to remove it
This study is designed to assess if computed tomography CT CAT-scan enhanced with intravenous contrast agent dye can characterize a lung cancer and say whether it is alive or dead The researchers hope that in the future such a contrast-enhanced CAT-scan will make surgery less often necessary or improve the results of chemotherapy andor radiation given before surgery
This study is designed to assess if computed tomography CT CAT-scan enhanced with intravenous contrast agent dye can characterize a lung cancer and say whether it is alive or dead The researchers hope that in the future such a contrast-enhanced CAT-scan will make surgery less often necessary or improve the results of chemotherapy andor radiation given before surgery
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None