MRI in Diagnosing Solid Tumors of the Eye and Orbit
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|ClinicalTrials.gov Identifier: NCT01653080|
Recruitment Status : Recruiting
First Posted : July 30, 2012
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Eye Cancer||Procedure: dynamic contrast-enhanced MRI||Not Applicable|
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.
Patients undergo DCE-MRI.
After completion of study treatment, patients are followed up every 6 months for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit.|
|Study Start Date :||June 2004|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- Diagnosis of benign vs. malignant lesions using DCE-MRI [ Time Frame: Up to 5 years ]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 [ Time Frame: Up to 5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01653080
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Michael Knopp, MDfirstname.lastname@example.org|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Michael V. Knopp 614-293-9998 email@example.com|
|Principal Investigator: Michael V. Knopp, MD|
|Sub-Investigator: Mohamed Abdel-Rahman, MD, Ph.D|
|Sub-Investigator: John Christofordis, MD|
|Sub-Investigator: Frederick Davidorf, MD|
|Sub-Investigator: Steffen Sammet, MD, Ph.D.|
|Principal Investigator:||Michael Knopp||Ohio State University Comprehensive Cancer Center|