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

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00751543
• Other study ID #: 200705059R
• Status: Recruiting
• Phase: N/A
• First received: September 10, 2008
• Last updated: June 28, 2010
• Start date: January 2008

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Chang Yeun-Chung, Ph.D
• Phone: 886-2-23123456
• Email: ycc5566[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: National Bureau of Controlled DrugsUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 and up

• Males and females

Exclusion Criteria:

• Pregnancy

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Carcinoma, Squamous Cell
• Lung Neoplasms
• Relevant Condition Terms to the Conditions Field
• Squamous Cell Carcinoma

Intervention

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

Locations

Country	Name	City	State
Taiwan	Yeun-Chung Chang	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Dec, 2008	Yes
Secondary	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).		Dec, 2008	Yes