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Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors

This study is currently recruiting participants.
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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

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 June 17, 2013