Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eye Cancer
- Sponsor
- University of Cincinnati
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Diagnosis of benign vs. malignant lesions using DCE-MRI
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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 Description
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.
Investigators
Michael V Knopp MD PhD
Principal Investigator
University of Cincinnati
Eligibility Criteria
Inclusion Criteria
- •The patient has an orbital mass which needs further diagnostic evaluation before treatment or for monitoring
- •Able to give informed consent
- •Return for follow-up visits
Exclusion Criteria
- •Patients with a lesion \< 2 mm
- •The patient should not participate in this study is any of the following applies to the patient: the patients has a pacemaker, metallic cardiac valve(s), magnetic material such as surgical clips, implanted electronic infusion pumps or any other condition that would interfere with the MRI, the patient has a stent somewhere in the body, the patient has a history of allergic reaction to any metals, contrast agents, x-ray dyes, the patient has claustrophobia
- •Patients cannot be pregnant and prisoners will not be considered for the study
- •Exposure to gadolinium-based contrast agents increases the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or severe renal dysfunction; therefore, patients with the following conditions are excluded from the study:
- •Acute or chronic severe renal insufficiency (glomerular filtration rate \< 30 mL/min/1.73 m\^2)
- •Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
- •In order to identify subjects at risk for the development of NSF, the American College of Radiology (http://acr.org) recommends obtaining a medical history and a glomerular filtration rate (GFR) assessment within six weeks of MR imaging in the following patients:
- •Renal disease (including solitary kidney, renal transplant, renal tumor)
- •Age \> 60
- •History of hypertension
Outcomes
Primary Outcomes
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.