Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by The S.N. Fyodorov Eye Microsurgery State Institution
Sponsor:
Information provided by (Responsible Party):
Yarovoy Andrey, The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier:
NCT01772355
First received: January 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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
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: 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

No publications provided by The S.N. Fyodorov Eye Microsurgery State Institution

Additional 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
Study First Received: January 17, 2013
Last Updated: January 17, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
United States: Federal Government

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

ClinicalTrials.gov processed this record on August 28, 2014