Multiparametric Characterization of Orbital Tumors by MRI

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sa-Ra Ro, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01884207
First received: June 6, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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.


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

  Eligibility

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

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
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: NCT01884207

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

No publications provided

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
Study First Received: June 6, 2013
Last Updated: June 17, 2014
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on July 23, 2014