MRI in Diagnosing Solid Tumors of the Eye and Orbit

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Eye Cancer
• Intervention / Treatment: Procedure: dynamic contrast-enhanced MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Knopp, MD; Phone Number: 614-293-9998; Email: knopp.16@osu.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dynamic contrast-enhanced MRI; Patients undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)

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.; Other Names: DCE-MRI; Magnetic Resonance Imaging; Dynamic Contrast Enhanced

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Improved characterization of different malignant tumor types	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.	Up to 5 years

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Investigators: Principal Investigator: Michael Knopp, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2006
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 26, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimated): July 30, 2012

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Eye; Solid Tumor; Orbit
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Eye Diseases; Eye Neoplasms
• Other Study ID Numbers: OSU-0361; NCI-2012-00957 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes