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

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: X-ray

• Registration Number: NCT01156454
• Lead Sponsor: University of Arkansas

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2011-01
• Study Completion: 2012-01
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-22
• Last Update Posted: 2016-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgery followed by x-ray assessment	X-ray	After nodes are removed they are taken to radiology to be x-rayed

Primary Outcome Measures

Name	Time	Method
Identification of lymph nodes	Within the first 30 minutes after specimen is removed from the body	To determine if plain x-ray films obtained from the sentinel node/axillary dissection specimen can facilitate the identification of the lymph nodes and increase the average number of lymph nodes recovered by the pathologist.
Identification of affected area in node	Within the first 30 minutes after specimen is removed from the body	To determine whether plain x-ray films obtained from the sentinel node/axillary dissection specimen can help direct the pathologist to the correct part of the node (the portion containing disease) to sample.

Trial Locations

Locations (1)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States