Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI
Recruitment status was Recruiting
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| First Received Date ICMJE | September 12, 2005 | ||||||||
| Last Updated Date | September 12, 2005 | ||||||||
| Start Date ICMJE | December 2004 | ||||||||
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| Change History | No Changes Posted | ||||||||
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| Brief Title ICMJE | Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI | ||||||||
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| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective |
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| Condition ICMJE | Lung Neoplasms | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 60 | ||||||||
| Completion Date | December 2006 | ||||||||
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| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
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| Location Countries ICMJE | Taiwan | ||||||||
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| NCT Number ICMJE | NCT00172575 | ||||||||
| Other Study ID Numbers ICMJE | 9361701184 | ||||||||
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| Study Sponsor ICMJE | National Taiwan University Hospital | ||||||||
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| Information Provided By | National Taiwan University Hospital | ||||||||
| Verification Date | December 2004 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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