Multiparametric Characterization of Orbital Tumors by MRI

This study has been completed.
Information provided by (Responsible Party):
Sa-Ra Ro, Charite University, Berlin, Germany Identifier:
First received: June 6, 2013
Last updated: December 22, 2015
Last verified: December 2015
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 Intervention
Orbital Tumors
Other: MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • multiparametric characterization of orbital tumors by MRI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

Enrollment: 65
Study Start Date: May 2013
Study Completion Date: December 2015
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01884207

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

Responsible Party: Sa-Ra Ro, doctoral candidate, Charite University, Berlin, Germany Identifier: NCT01884207     History of Changes
Other Study ID Numbers: MCOT_03_05 
Study First Received: June 6, 2013
Last Updated: December 22, 2015
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Orbital Neoplasms
Bone Diseases
Bone Neoplasms
Eye Diseases
Eye Neoplasms
Musculoskeletal Diseases
Neoplasms by Site
Orbital Diseases
Skull Neoplasms processed this record on May 04, 2016