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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: X-ray

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Males or females of all races and ethnicities, must be equal to or greater than 18 years of age, scheduled for breast cancer surgery that includes sentinel node biopsy and/or axillary dissection

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgery followed by x-ray assessment; After nodes are removed they are taken to radiology to be x-rayed	Procedure: X-ray; surgical specimen taken to radiology and contents x-rayed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of lymph nodes	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.	Within the first 30 minutes after specimen is removed from the body
Identification of affected area in node	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.	Within the first 30 minutes after specimen is removed from the body

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: Tenenbaum Family Foundation
• Investigators: Principal Investigator: V. Suzanne Klimberg, MD, UAMS

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: June 24, 2010
• First Submitted That Met QC Criteria: July 1, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): December 23, 2016
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: radiology; sentinel lymph node dissection; X-ray identification of nodes in a surgical specimen
• Other Study ID Numbers: 111743