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ACTIVE NOT RECRUITING

NCT01653080

MRI in Diagnosing Solid Tumors of the Eye and Orbit

Sponsor: University of Cincinnati

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2006-05-18

Completion Date

2026-12-31

Last Updated

2025-04-11

Healthy Volunteers

Conditions

Eye Cancer

Interventions

PROCEDURE

dynamic contrast-enhanced MRI

Studies will be performed on standard clinical MR Systems which are available on Campus. With the proposed imaging technique, we are able to acquire a 3D volume covering the orbit with a temporal resolution of approximately 15s. The affected eye will be immobilized to reduce motion artifacts. A routinely used MR contrast agent will be administered in a dose of 0.1mmol/kg bodyweight.

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 * History of diabetes * History of severe hepatic disease/liver transplant/pending liver transplant * All subjects providing written informed consent will complete the subject history and screening form prior to MR imaging; the form will be reviewed to determine whether the subject is at risk as defined above and the availability of an estimated glomerular filtration rate (eGFR) within six weeks of anticipated MR imaging; an eGFR result greater than six weeks prior to the MRI imaging date will be repeated and evaluated for renal function; subjects with an eGFR of \< 30 mL/min/1.73 m\^2 will be excluded from the study

Locations (1)

Ohio State University Medical Center

Columbus, Ohio, United States