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

This study has been completed.
Sponsor:
Collaborator:
Tenenbaum Family Foundation
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01156454
First received: June 24, 2010
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Procedure: X-ray
 Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Specimen X-Rays of Removed Axillary Lymph Nodes to Guide Pathological Sampling (GPS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Identification of lymph nodes [ Time Frame: Within the first 30 minutes after specimen is removed from the body ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within the first 30 minutes after specimen is removed from the body ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156454

Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Tenenbaum Family Foundation
Investigators
Principal Investigator: V. Suzanne Klimberg, MD UAMS
  More Information

Publications:

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01156454     History of Changes
Other Study ID Numbers: 111743
Study First Received: June 24, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arkansas:
sentinel lymph node dissection
radiology
X-ray identification of nodes in a surgical specimen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013