Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI
|ClinicalTrials.gov Identifier: NCT00172575|
Recruitment Status : Unknown
Verified December 2004 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
|Condition or disease|
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.
|Study Type :||Observational|
|Enrollment :||60 participants|
|Observational Model:||Defined Population|
|Study Start Date :||December 2004|
|Study Completion Date :||December 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00172575
|Contact: Jane Wang, MD||886-2-23123456 ext firstname.lastname@example.org|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Jane Wang, MD 886-2-23123456 ext 5565 email@example.com|
|Sub-Investigator: Jane Wang, MD|
|Principal Investigator: Tiffany Ting-Fang Shih, MD|
|Study Director:||Pan-Chyr Yang, PhD||National Taiwan University Hospital|
|Study Chair:||Tiffany Ting-Fang Shih, MD||National Taiwan University Hospital|