Clinical Trial: MRI in Diagnosing Solid Tumors of the Eye and Orbit

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit.

Brief Summary: This study is being done due to a new imaging method that may help others in the future to improve evaluation of diseases in the eye and eye socket and to help make a decision concerning best treatment of the disease. Previous studies suggests that dynamic contrast enhanced MRI is ideally suited to show small structures in the eye and eye socket as well as to provide information about the eye socket such as blood circulation. This research may also provide information about the likelihood of the tumor spreading from the eye into other organs as well as correlate the study images with all other clinical imaging

Detailed Summary:

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.

Current Primary Outcome:

• Diagnosis of benign vs. malignant lesions using DCE-MRI [ Time Frame: Up to 5 years ]
  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.
• Improved characterization of different malignant tumor types [ Time Frame: Up to 5 years ]
  Logistic regression models will be applied to determine the factors most predictive of malignancy using forward selection methods described in Hosmer-Lemeshow goodness-of-fit test as well as the area under the Receiver-Operator Characteristic (ROC) curve. Outliers and influential covariate patterns will be identified using diagnostic plots. Depending on the complexity of the models, exact methods may be necessary.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ohio State University Comprehensive Cancer Center

Dates:
Date Received: July 26, 2012
Date Started: June 2004
Date Completion:
Last Updated: September 25, 2014
Last Verified: September 2014