Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit.
PRIMARY OBJECTIVES:
I. To determine the feasibility of DCE-MRI (dynamic contrast enhanced magnetic resonance
imaging) as non-invasive imaging tool to image contrast enhancement in ocular and orbital
tumors.
II. To compare contrast enhancement and its distribution within orbital tissue. III. To
assess potential differences in contrast enhancement which help to characterize malignant
lesions as well as discriminate these from benign tissue.
IV. To compare image characteristics between clinical high field end ex-vivo ultra high
field magnetic resonance (MR) imaging.
V. To correlate imaging findings with obtained histology by comparing contrast enhancement
parameters, e.g. maximum signal intensity, to histology characteristics, e.g. vascular
density.
OUTLINE:
Patients undergo DCE-MRI.
After completion of study treatment, patients are followed up every 6 months for up to 5
years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Diagnosis of benign vs. malignant lesions using DCE-MRI
Crude comparisons between the groups of patients (benign vs. malignant) will be performed using a one-way ANOVA or nonparametric Wilcoxon Rank Sum test, where appropriate. Outliers and influential covariate patterns will be identified using diagnostic plots. Depending on the complexity of the models, exact methods may be necessary.
Up to 5 years
No
Michael Knopp
Principal Investigator
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
OSU-0361
NCT01653080
June 2004
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |