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

Phase 1
18 Years
Open (Enrolling)
Eye Cancer

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Trial Information

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


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

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


Patients undergo DCE-MRI.

After completion of study treatment, patients are followed up every 6 months for up to 5

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 ( 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Diagnosis of benign vs. malignant lesions using DCE-MRI

Outcome Description:

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.

Outcome Time Frame:

Up to 5 years

Safety Issue:


Principal Investigator

Michael Knopp

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Eye Cancer
  • Solid Tumor
  • Eye
  • Orbit
  • Eye Neoplasms



Ohio State University Medical CenterColumbus, Ohio  43210