Effectiveness and Possible Complications of Core Needle Biopsy of Orbital Tumors
Sponsor
Yarovoy Andrey (Other)
Overall Status
Unknown status
CT.gov ID
NCT01772355
Collaborator
(none)
75
1
1
68
1.1
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Study Start Date
:
Oct 1, 2008
Actual Primary Completion Date
:
Dec 1, 2012
Anticipated Study Completion Date
:
Jun 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: tissue core semi automated core needle biopsy of the orbital tumors |
Device: semi automated core needle biopsy of orbital tumors
|
Outcome Measures
Primary Outcome Measures
- true identification of an orbital tumor with a core needle biopsy [five years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The S.Fyodorov Eye Microsurgery Federal State Institution | Moscow | Russian Federation | 127486 |
Sponsors and Collaborators
- Yarovoy Andrey
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Yarovoy Andrey,
MD, PhD, head ocular oncology department,
The S.N. Fyodorov Eye Microsurgery State Institution
ClinicalTrials.gov Identifier:
NCT01772355
Other Study ID Numbers:
- core biopsy of orbital tumors
First Posted:
Jan 21, 2013
Last Update Posted:
Jan 21, 2013
Last Verified:
Jan 1, 2013
Keywords provided by Yarovoy Andrey,
MD, PhD, head ocular oncology department,
The S.N. Fyodorov Eye Microsurgery State Institution