- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00172575
Differentiation of Malig. & Ben. Solitary Pulm. Nodules & Prediction of Clin. Outcome Using Perfus. Analysis of DCEMRI
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving
Contacten en locaties
Studie Locaties
-
-
-
Taipei, Taiwan, 100
- Werving
- National Taiwan University Hospital
-
Contact:
- Jane Wang, MD
- Telefoonnummer: 5565 886-2-23123456
- E-mail: hstjen@yahoo.com.tw
-
Onderonderzoeker:
- Jane Wang, MD
-
Hoofdonderzoeker:
- Tiffany Ting-Fang Shih, MD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- patients who have solitary pulmonary nodules in CT
Exclusion Criteria:
- patients who don't fit the above inclusion criteria
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Pan-Chyr Yang, PhD, National Taiwan University Hospital
- Studie stoel: Tiffany Ting-Fang Shih, MD, National Taiwan University Hospital
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 9361701184
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .