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

NCT ID: NCT00172575

Last Updated: 2005-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2006-12-31

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.

Conditions

Lung Neoplasms

Keywords

Lung neoplasms; Magnetic resonance imaging

Study Design

• Observational Model Type: DEFINED_POPULATION
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

• patients who have solitary pulmonary nodules in CT

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Pan-Chyr Yang, PhD

Role: STUDY_DIRECTOR

National Taiwan University Hospital

Tiffany Ting-Fang Shih, MD

Role: STUDY_CHAIR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jane Wang, MD

Role: CONTACT

Phone: 886-2-23123456

Email: hstjen@yahoo.com.tw

Facility Contacts

Jane Wang, MD

Role: primary

References

Schaefer JF, Vollmar J, Schick F, Vonthein R, Seemann MD, Aebert H, Dierkesmann R, Friedel G, Claussen CD. Solitary pulmonary nodules: dynamic contrast-enhanced MR imaging--perfusion differences in malignant and benign lesions. Radiology. 2004 Aug;232(2):544-53. doi: 10.1148/radiol.2322030515. Epub 2004 Jun 23.

Reference Type: BACKGROUND

PMID: 15215548 (View on PubMed)

Yi CA, Lee KS, Kim EA, Han J, Kim H, Kwon OJ, Jeong YJ, Kim S. Solitary pulmonary nodules: dynamic enhanced multi-detector row CT study and comparison with vascular endothelial growth factor and microvessel density. Radiology. 2004 Oct;233(1):191-9. doi: 10.1148/radiol.2331031535. Epub 2004 Aug 10.

Reference Type: BACKGROUND

PMID: 15304661 (View on PubMed)

Other Identifiers

9361701184

Identifier Type: -

Identifier Source: org_study_id