Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling

NCT ID: NCT01156454

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-01-31

Brief Summary

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X-ray mapping of sentinel lymph nodes and/or axillary tissue will assist pathologists in their ability to identify the number and location of lymph nodes as well as more accurately section lymph nodes contained in surgical specimens.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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sentinel lymph node dissection radiology X-ray identification of nodes in a surgical specimen

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery followed by x-ray assessment

After nodes are removed they are taken to radiology to be x-rayed

X-ray

Intervention Type PROCEDURE

surgical specimen taken to radiology and contents x-rayed

Interventions

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X-ray

surgical specimen taken to radiology and contents x-rayed

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Males or females of all races and ethnicities

* ≥ 18 years of age
* Must be scheduled for breast cancer surgery which includes a sentinel lymph node biopsy and/or axillary dissection

Exclusion Criteria

• Any person whose final pathology could be compromised in any way by the X-ray procedure
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tenenbaum Family Foundation

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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V. Suzanne Klimberg, MD

Role: PRINCIPAL_INVESTIGATOR

UAMS

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

References

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Johnson CB, Korourian S, Badgwell BD, Fincher RL, Dell CM, Don Bice C, Boneti C, Westbrook KC, Klimberg VS. Sensitivity of axillary specimen x-ray to predict nodal count and positivity. Ann Surg Oncol. 2011 Oct;18(11):3181-6. doi: 10.1245/s10434-011-1959-x. Epub 2011 Aug 23.

Reference Type RESULT
PMID: 21861231 (View on PubMed)

Other Identifiers

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111743

Identifier Type: -

Identifier Source: org_study_id