Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Eye Cancer | Malignant Eye Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dynamic contrast-enhanced MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dynamic contrast-enhanced MRI
- description
- Patients undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)
- interventionNames
- Procedure: dynamic contrast-enhanced MRI
Primary outcomes (2)
- measure
- Diagnosis of benign vs. malignant lesions using DCE-MRI
- timeFrame
- Up to 5 years
- 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.
- measure
- Improved characterization of different malignant tumor types
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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