Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172575
Status:
UNKNOWN
Last Update Posted:
2005-09-15
First Post:
2005-09-12
Brief Title:
Differentiation of Malig Ben Solitary Pulm Nodules Prediction of Clin Outcome Using Perfus Analysis of DCEMRI
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2004-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None