CT Perfusion Scans for Assessment of Lung Cancer Before and After Chemo +/- Radiotherapy - Full Text View

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188214

Purpose

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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Procedure: contrast-enhanced dynamic CT perfusion study	Phase II

MedlinePlus related topics: Cancer Lung Cancer Nuclear Scans Radiation Therapy Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo-/ Radiotherapy

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

-Analysis will be performed to yield quantitative, absolute estimates of blood volume, blood flow, and microvascular permeability. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Intervention Details:

contrast-enhanced dynamic CT perfusion study pre treatment and post treatment

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188214

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Heidi C Roberts, MD

University Health Network, Toronto

More Information

No publications provided

Responsible Party:	University Health Network ( Dr. Heidi Roberts )
Study ID Numbers:	03-0420-CE
Study First Received:	September 9, 2005
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00188214 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University Health Network, Toronto:

perfusion
CT
CAT
non-small
lung

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases

Non-small Cell Lung Cancer
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Respiratory Tract Diseases

Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

ClinicalTrials.gov processed this record on May 07, 2009