Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01653080
Other study ID # OSU-0361
Secondary ID NCI-2012-00957
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 18, 2006
Est. completion date December 31, 2024

Study information

Verified date January 2024
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Ohio State University Medical Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Withdrawn NCT01151748 - Intra-arterial Chemotherapy for Advanced Intraocular Retinoblastoma Phase 2
Completed NCT00588640 - Study of D-Methadone in Patients With Chronic Pain Phase 1/Phase 2
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A
Completed NCT05853315 - BCC Excision Revisited
Completed NCT00020267 - Vaccine Therapy in Treating Patients With Metastatic Cancer Phase 1
Completed NCT05236049 - Use of an Allograft Set-up (SclerFIX) as Replacement of Sclera Graft for Support of Enucleation Implant Phase 1
Completed NCT00601744 - Social-Psychological Aspects of Orbital Exenteration N/A
Completed NCT01072253 - Quality of Life of Eye Amputated Patients in Denmark N/A

External Links