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MRI in Diagnosing Solid Tumors of the Eye and Orbit

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Michael Knopp, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01653080
First received: July 26, 2012
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Eye Cancer
Procedure: dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Dynamic Contrast Enhanced Magnetic Resonance Imaging for Non-Invasive Diagnostic Work-Up in Solid Tumors of the Eye and Orbit.

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • Diagnosis of benign vs. malignant lesions using DCE-MRI [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: June 2004
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dynamic contrast-enhanced magnetic resonance imaging
Patients undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI)
Procedure: dynamic contrast-enhanced magnetic resonance imaging (DCE-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.
Other Names:
  • DCE-MRI
  • Dynamic Contrast Enhanced
  • Magnetic Resonance 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01653080

Contacts
Contact: The Ohio State University Comprehensive Cancer Center 1-800-293-5066 Jamesline@osumc.edu
Contact: Michael Knopp, MD 614-293-9998 knopp.16@osu.edu

Locations
United States, Ohio
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Michael V. Knopp    614-293-9998    knopp.16@osu.edu   
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.         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Michael Knopp Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Michael Knopp, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01653080     History of Changes
Other Study ID Numbers: OSU-0361, NCI-2012-00957
Study First Received: July 26, 2012
Last Updated: September 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Solid Tumor
Eye
Orbit

Additional relevant MeSH terms:
Eye Neoplasms
Eye Diseases
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2014