AdenocarcinomaNCT00751543
The Character of Perfusion Parameters Derived From MDCT Between Adenocarcinoma and Squamous Cell Carcinoma of Lung in the Treatment Course of Radiation Therapy
A study testing CT, radiation therapy in people with Adenocarcinoma and Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Squamous Cell Carcinoma, Relevant Condition Terms to the Conditions Field
- What is being tested?
- CT, radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 and up
- Males and females
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- CT, radiation therapy
- Keywords
- 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
- Medical subject headings
- Adenocarcinoma, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT, radiation therapyRadiation
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Dec, 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yeun-Chung Chang, Ph.D, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00751543
- Sponsor's protocol ID
- 200705059R
- Status last verified
- Jun 2010
- First submitted
- 10 Sep 2008
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00751543
- Acronym / sponsor ID
- 200705059R
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2010 (estimated)
- First posted
- 12 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 and up
- Males and females
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT, radiation therapyComputed 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 | Radiation | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeun-Chung Chang, Ph.D principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT, radiation therapy in people with Adenocarcinoma and Squamous Cell Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chang Yeun-Chung, Ph.D (886-2-23123456 ext. 65566, ycc5566@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.