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MRI in Diagnosing Solid Tumors of the Eye and Orbit

Primary Purpose

Eye Cancer

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

dynamic contrast-enhanced MRI

About this trial

This is an interventional diagnostic trial for Eye Cancer focused on measuring Solid Tumor, Eye, Orbit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dynamic contrast-enhanced MRI

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01653080

First Posted

July 26, 2012

Last Updated

June 28, 2023

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01653080

Brief Title

MRI in Diagnosing Solid Tumors of the Eye and Orbit

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 18, 2006 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Eye Cancer

Keywords

Solid Tumor, Eye, Orbit

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dynamic contrast-enhanced MRI

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

dynamic contrast-enhanced MRI

Other Intervention Name(s)

DCE-MRI, Dynamic Contrast Enhanced, Magnetic Resonance Imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

Diagnosis of benign vs. malignant lesions using DCE-MRI

Description

Time Frame

Up to 5 years

Title

Improved characterization of different malignant tumor types

Description

Time Frame

Up to 5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Knopp

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

Jamesline

Learn more about this trial

MRI in Diagnosing Solid Tumors of the Eye and Orbit

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