NCT00751543

Brief 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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

June 29, 2010

Status Verified

June 1, 2010

Enrollment Period

2.9 years

First QC Date

September 10, 2008

Last Update Submit

June 28, 2010

Conditions

Keywords

To evaluate the longitudinal change of tumor perfusion in the course of radiation therapy in adenocarcinoma and squamous cell carcinoma using perfusion MDCTComparison between adenocarcinoma and squamous cell carcinoma will be evaluated according to the derived perfusion parameter obtained from perfusion MDCT

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Interventions

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18 and up
  • Males and females

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeun-Chung Chang

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

AdenocarcinomaCarcinoma, Squamous Cell

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Yeun-Chung Chang, Ph.D

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Yeun-Chung, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 10, 2008

First Posted

September 12, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Last Updated

June 29, 2010

Record last verified: 2010-06

Locations