Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00172575
First received: September 12, 2005
Last updated: NA
Last verified: December 2004
History: No changes posted
  Purpose

The purpose of our study is to determine whether contrast-enhanced dynamic MRI (DCE MRI) analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant solitary pulmonary nodules (SPN) before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients’ outcomes and survival.


Condition
Lung Neoplasms

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 60
Study Start Date: December 2004
Estimated Study Completion Date: December 2006
Detailed Description:

The solitary pulmonary nodule (SPN) is a common finding in chest radiography. Pulmonary nodules larger than 1cm indicative of malignancy or with indeterminate finding according to morphology criteria have to be defined by invasive methods such as biopsy or surgical excision, and benign pathology makes up 20-50% of those resected pulmonary lesions. The lesions not receiving surgical intervention often need imaging follow-up on a regular basis for a long period of time to monitor the stability of the finding.

There are many reports regarding the MRI perfusion analysis of neoplasms from many organs, including bone marrow, liver, breast, cervix, and they stressed not only on comparison between benignity and malignancy, but also on monitoring the treatment outcomes after neoadjuvant chemotherapy, radiation therapy or anti-angiogenic agent therapy [7-15]. Dynamic contrast-enhanced MRI (DCE MRI) is not a standard examination for SPN, but there have been some data regarding the differentiation between malignant and benign SPN using DCE MRI, with MRI offering higher specificity compared to dynamic CT scan [6, 7, 16]. It was also reported that DCE MRI could delineate kinetic and morphologic differences in tumor angiogenesis and perfusion characteristics between malignant and benign pulmonary lesions with relatively high accuracy [7, 16]. The purpose of our study is to determine whether DCE MRI analysis of tumor angiogenesis and perfusion can be used as a reliable modality to differentiate benign from malignant SPN before surgical intervention, using kinetic model derived from DCE MRI, and further correlate if there is any positive correlation between angiogenesis factor (vascular endothelial growth factor VEGF, microvessel density MVD); and if the perfusion parameters from DCE MRI can predict patients’ outcomes and survival.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients who have solitary pulmonary nodules in CT

Exclusion Criteria:

  • patients who don't fit the above inclusion criteria
  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: NCT00172575

Contacts
Contact: Jane Wang, MD 886-2-23123456 ext 5565 hstjen@yahoo.com.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jane Wang, MD    886-2-23123456 ext 5565    hstjen@yahoo.com.tw   
Sub-Investigator: Jane Wang, MD         
Principal Investigator: Tiffany Ting-Fang Shih, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Pan-Chyr Yang, PhD National Taiwan University Hospital
Study Chair: Tiffany Ting-Fang Shih, MD National Taiwan University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00172575     History of Changes
Other Study ID Numbers: 9361701184
Study First Received: September 12, 2005
Last Updated: September 12, 2005
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Lung neoplasms
Magnetic resonance imaging

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 26, 2014