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Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01772355
First Posted: January 21, 2013
Last Update Posted: January 21, 2013
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.
Information provided by (Responsible Party):
Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution
  Purpose
Core needle biopsy of orbital mass lesions with a semiautomated needles is a safe procedure that provides a sufficient amount of tissue material for standard histological and immunohistochemical analysis and can be an alternative or supplement to fine needle aspiration biopsy

Condition Intervention
Orbial Mass Lesion Device: semi automated core needle biopsy of orbital tumors

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution:

Primary Outcome Measures:
  • true identification of an orbital tumor with a core needle biopsy [ Time Frame: five years ]

Estimated Enrollment: 75
Study Start Date: October 2008
Estimated Study Completion Date: June 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
tissue core
semi automated core needle biopsy of the orbital tumors
Device: semi automated core needle biopsy of orbital tumors

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unresectable mass lesions with diffuse involvement of the orbit or the tumors with infiltrative growth and indistinct borders which needed to have morphologic verification

Exclusion Criteria:

  • An anti-coagulant therapy at the time of biopsy,
  • bleeding diathesis,
  • suspected hypervascular lesions,
  • orbital roof destruction with a tumor,
  • apical location of the tumor
  Contacts and Locations
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): NCT01772355


Contacts
Contact: Andrey A Yarovoy, MD +74994888943 yarovoyaa@yandex.ru

Locations
Russian Federation
The S.Fyodorov Eye Microsurgery Federal State Institution Recruiting
Moscow, Russian Federation, 127486
Contact: Andrey A Yarovoy, MD    +74994888943    yarovoyaa@yandex.ru   
Sponsors and Collaborators
Yarovoy Andrey
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yarovoy Andrey, MD, PhD, head ocular oncology department, The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier: NCT01772355     History of Changes
Other Study ID Numbers: core biopsy of orbital tumors
First Submitted: January 17, 2013
First Posted: January 21, 2013
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution:
orbit; tumor; core biopsy