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Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

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ClinicalTrials.gov Identifier: NCT01154972
Recruitment Status : Unknown
Verified June 2010 by NHS Tayside.
Recruitment status was:  Recruiting
First Posted : July 1, 2010
Last Update Posted : July 14, 2010
University of Dundee
Information provided by:
NHS Tayside

Brief Summary:
When a person has breast cancer it is necessary to find out whether the cancer has spread to the lymph nodes in the armpit because if it has, further treatment is likely to be needed. There are many of these nodes but when the breast cancer spreads, it does so in a step-by-step fashion, starting with the so-called Sentinel Lymph Node (SLN). At present, the only way to be sure whether there is cancer in the lymph nodes or not is to perform an operation to remove at least the SLN. If the pathologist finds cancer in the SLN, a second operation is usually required to remove further nodes in case they contain cancer too. Surgical removal of the lymph nodes in the armpit can cause difficulties for the patient afterwards, such as pain and swelling in the arm. If there is no cancer in the SLN, no further operations on the armpit are needed. The investigators wish to find out whether in some patients, operations on the armpit can be avoided completely. The first step in doing this is to test whether the investigators can find out which is the SLN before the operation, using a combination of an injection and ultrasound scanning. The injection - into the skin of the breast - would be a radioactive substance, which is the usual way the surgeon finds the SLN. The radioactive substance collects in the SLN and the investigators would use a "gamma probe" over the surface of the armpit to detect the radiation. In this initial study, the investigators would aim to find the SLN before the operation and place a marker wire in it so that the surgeon could check whether the investigators had found the correct node.

Condition or disease Intervention/treatment
Breast Cancer Procedure: Preoperative sentinel lymph node identification and marking

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Preoperative Identification of the Sentinel Lymph Node in Breast Cancer, Using Ultrasound and Radio-isotope/Percutaneous Gamma Probe
Study Start Date : April 2010
Estimated Primary Completion Date : October 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    Procedure: Preoperative sentinel lymph node identification and marking
    SLN is identified using gamma probe and ultrasound. Percutaneous wire placement carried out to mark SLN for subsequent surgical verification.

Primary Outcome Measures :
  1. Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery? [ Time Frame: 8 Months from start of trial. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with invasive breast cancer suitable for primary surgical treatment
  • Booked for surgical Sentinel Lymph Node Biopsy

Exclusion Criteria:

  • Unable to give informed consent
  • Known bleeding disorder
  • Previous axillary surgery
  • Previously treated for the current tumour with chemotherapy or hormone therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154972

Contact: Andrew Evans, FRCR +44 (0)1382 632196 a.z.evans@dundee.ac.uk
Contact: Patsy Whelehan, MSc +44 (0)1382 496426 p.j.whelehan@dundee.ac.uk

United Kingdom
Ninewells Hospital and Medical School Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Andrew Evans, FRCR    +44 (0)1382 632196    a.z.evans@dundee.ac.uk   
Sub-Investigator: Douglas Brown, FRCS         
Sponsors and Collaborators
NHS Tayside
University of Dundee

Responsible Party: Professor Andy Evans, University of Dundee
ClinicalTrials.gov Identifier: NCT01154972     History of Changes
Other Study ID Numbers: 2010ON03
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 14, 2010
Last Verified: June 2010

Keywords provided by NHS Tayside:
sentinel lymph node

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