MRI in Diagnosing Solid Tumors of the Eye and Orbit

NCT01653080 | Active Not Recruiting DMC FDA Device

• 2 other identifiers: OSU-0361NCI-2012-00957
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Eye Cancer

Keywords

Solid Tumor; Eye; Orbit

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Dynamic contrast-enhanced MRI

EXPERIMENTAL

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

Procedure: dynamic contrast-enhanced MRI

Interventions

dynamic contrast-enhanced MRI PROCEDURE

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.

Also known as: DCE-MRI, Dynamic Contrast Enhanced, Magnetic Resonance Imaging

Dynamic contrast-enhanced MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• Jamesline

MeSH Terms

Conditions

Eye Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Eye Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Michael Knopp

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: May 18, 2006
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

US (1)