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

Breast Cancer Clinical Trial

— GPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01156454
• Other study ID #: 111743
• Status: Completed
• Phase: Phase 1
• First received: June 24, 2010
• Last updated: December 22, 2016
• Start date: November 2009
• Est. completion date: January 2012

Study information

• Verified date: December 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• X-ray
surgical specimen taken to radiology and contents x-rayed

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Tenenbaum Family Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No