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Multiparametric Characterization of Orbital Tumors by MRI

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ClinicalTrials.gov Identifier: NCT01884207
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sa-Ra Ro, Charite University, Berlin, Germany

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
orbital tumors Other: MRI


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Inclusion Criteria:

  • non-diagnosed orbital tumors

Exclusion Criteria:

  • any metal implants, non-MRI compatible
  • age below 18
  • pregnancy
  • recent surgery
  • recent severe medical diseases
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT01884207


Locations
Germany
Charite University
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Sa-Ra Ro, doctoral candidate, Charite University, Berlin, Germany
ClinicalTrials.gov 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
Neoplasms
 Eye Neoplasms
Bone Diseases
Musculoskeletal Diseases
Eye Diseases
Orbital Diseases