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

NCT01156454 | Completed

• 1 other identifier: 111743
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Surgery followed by x-ray assessment

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

Procedure: X-ray

Interventions

X-ray PROCEDURE

surgical specimen taken to radiology and contents x-rayed

Surgery followed by x-ray assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Arkansas: lead
• Tenenbaum Family Foundation: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related 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-x. Epub 2011 Aug 23.

  PMID: 21861231 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• V. Suzanne Klimberg, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: July 2, 2010
• Study Start: November 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

US (1)