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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188214
First received: September 9, 2005
Last updated: September 3, 2014
Last verified: September 2014
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic CT Perfusion for Assessment of Lung Cancer Before and After Neoadjuvant Chemo-/ Radiotherapy

Resource links provided by NLM:


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 ]

Enrollment: 38
Study Start Date: October 2003
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CT perfusion scan Procedure: contrast-enhanced dynamic CT perfusion study
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Toronto
ClinicalTrials.gov Identifier: NCT00188214     History of Changes
Other Study ID Numbers: 03-0420-CE
Study First Received: September 9, 2005
Last Updated: September 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
perfusion
CT
CAT
non-small
lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2014