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Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

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ClinicalTrials.gov Identifier: NCT01772355
Recruitment Status : Unknown
Verified January 2013 by Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution.
Recruitment status was:  Recruiting
First Posted : January 21, 2013
Last Update Posted : January 21, 2013
Sponsor:
Information provided by (Responsible Party):
Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution

Brief Summary:
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 or disease Intervention/treatment Phase
Orbial Mass Lesion Device: semi automated core needle biopsy of orbital tumors Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : October 2008
Actual Primary Completion Date : December 2012
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy
U.S. FDA Resources

Arm Intervention/treatment
tissue core
semi automated core needle biopsy of the orbital tumors
Device: semi automated core needle biopsy of orbital tumors



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


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

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

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 Posted: January 21, 2013    Key Record Dates
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