Multiparametric Characterization of Orbital Tumors by MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01884207
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : December 23, 2015
Information provided by (Responsible Party):
Sa-Ra Ro, Charite University, Berlin, Germany

Brief Summary:
Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. These advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). These MRI data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. Cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors.

Condition or disease Intervention/treatment
Orbital Tumors Other: MRI

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2015

Group/Cohort Intervention/treatment
orbital tumors Other: MRI

Primary Outcome Measures :
  1. multiparametric characterization of orbital tumors by MRI [ Time Frame: 24 months ]
    The level of diffusion and perfusion (multiparametric characterization) of the orbital tumors will be measured and the outcome measure is the ability of diffusion and perfusion imaging to predict malignancy. These parameters will be compared to histopathology in terms of separating benign vs. malignant tumors.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with orbital tumors

Inclusion Criteria:

  • non-diagnosed orbital tumors

Exclusion Criteria:

  • any metal implants, non-MRI compatible
  • age below 18
  • pregnancy
  • recent surgery
  • recent severe medical diseases

Information from the National Library of Medicine

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 identifier (NCT number): NCT01884207

Charite University
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany

Responsible Party: Sa-Ra Ro, doctoral candidate, Charite University, Berlin, Germany Identifier: NCT01884207     History of Changes
Other Study ID Numbers: MCOT_03_05
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Orbital Neoplasms
Skull Neoplasms
Bone Neoplasms
Neoplasms by Site
Eye Neoplasms
Bone Diseases
Musculoskeletal Diseases
Eye Diseases
Orbital Diseases