The Character of Perfusion Parameters Derived From MDCT Between Adenocarcinoma and Squamous Cell Carcinoma of Lung in the Treatment Course of Radiation Therapy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00751543
First received: September 10, 2008
Last updated: June 28, 2010
Last verified: June 2010
  Purpose

Lung cancer is one of the leading causes of cancer-related death in Taiwan. Recently, there are more treatment methods available which result in increased patient survival. Although adenocarcinoma and squamous cell carcinoma were both categorized as non-small cell lung cancer (NSCLC), the recent advancement of target therapy implied that these two histologies behave differently (Shah NT, et al. 2005; Sandler A, et al. 2006). Radiation therapy is an important method for locally advanced non-resectable non-small cell lung cancer (NSCLC). Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed evaluation of tissue and organ perfusion with excellent resolution. Using this new technique with image post processing, excellent spatial resolution and functional perfusion information can be obtained simultaneously. Therefore, the purpose of this study is to explore not only the longitudinal change of lung cancer eligible for radiation therapy (including concurrent, sequential chemoradiotherapy and high-dose radiation therapy) but also comparison of adenocarcinoma and squamous cell lung cancers using perfusion MDCT. Total twenty patients with histopathologically proved adenocarcinoma or squamous cell carcinoma will be enrolled in this study and receive longitudinal study for perfusion MDCT evaluation before, during radiation therapy and in early and late phases after complete radiation therapy. Dynamic perfusion will be used for processing the image data, and quantitative parameters such as tumor blood volume and permeability etc will be derived. From this study, we expect to understand the change of tumor vascularity after radiation therapy and characters of treatment response of adenocarcinoma and squamous cell carcinoma in addition to the change of tumor size.


Condition Intervention
Adenocarcinoma
Squamous Cell Carcinoma
Relevant Condition Terms to the Conditions Field
Radiation: CT, radiation therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Character of Perfusion Parameters Derived From MDCT Between Adenocarcinoma and Squamous Cell Carcinoma of Lung in the Treatment Course of Radiation Therapy

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • This study will provide information of quantitative measurement of lung cancer, in term of tumor permeability (mL/100 mL/min) and blood volume (mL/100 mL), in addition to tumor size. [ Time Frame: Dec, 2008 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The information may be beneficial to understand the longitudinal change of internal tumor vascular composition following radiation therapy and between tumors of different histopathology (i.e. adenocarcinoma vs. squamous cell carcinoma). [ Time Frame: Dec, 2008 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2008
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: CT, radiation therapy
    Computed tomography (CT) is the mainstay for evaluating lung cancer. The advance of multi-row detector CT (MDCT) provides volumetric acquisition within a breath hold, and enables detailed evaluation of tissue and organ perfusion with excellent resolution
  Eligibility

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

Inclusion Criteria:

  • Ages 18 and up
  • Males and females

Exclusion Criteria:

  • Pregnancy
  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: NCT00751543

Contacts
Contact: Chang Yeun-Chung, Ph.D 886-2-23123456 ext 65566 ycc5566@ntu.edu.tw

Locations
Taiwan
Yeun-Chung Chang Recruiting
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yeun-Chung Chang, Ph.D National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Yeun-Chung Chang / Department of Medical Imaging, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00751543     History of Changes
Other Study ID Numbers: 200705059R
Study First Received: September 10, 2008
Last Updated: June 28, 2010
Health Authority: Taiwan: National Bureau of Controlled Drugs
United States: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
To evaluate the longitudinal change of tumor perfusion in the course of radiation therapy in adenocarcinoma and squamous cell carcinoma using perfusion MDCT
Comparison between adenocarcinoma and squamous cell carcinoma will be evaluated according to the derived perfusion parameter obtained from perfusion MDCT

Additional relevant MeSH terms:
Disease
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma
Lung Neoplasms
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014