CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo +/- Radiotherapy
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
contrast-enhanced dynamic CT perfusion study
Sponsored by
About this trial
This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring perfusion, CT, CAT, non-small, lung
Eligibility Criteria
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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
CT perfusion scan
Arm Description
Outcomes
Primary Outcome Measures
-Analysis will be performed to yield quantitative, absolute estimates of blood volume, blood flow, and microvascular permeability.
Secondary Outcome Measures
Full Information
NCT ID
NCT00188214
First Posted
September 9, 2005
Last Updated
May 3, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00188214
Brief Title
CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo +/- Radiotherapy
Official Title
Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo-/ Radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 and/or 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 and/or 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
perfusion, CT, CAT, non-small, lung
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT perfusion scan
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
contrast-enhanced dynamic CT perfusion study
Intervention Description
contrast-enhanced dynamic CT perfusion study pre treatment and post treatment
Primary Outcome Measure Information:
Title
-Analysis will be performed to yield quantitative, absolute estimates of blood volume, blood flow, and microvascular permeability.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi C Roberts, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo +/- Radiotherapy
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