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Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

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ClinicalTrials.gov Identifier: NCT01154972
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : May 11, 2018
Sponsor:
Collaborator:
University of Dundee
Information provided by (Responsible Party):
Andy Evans, 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 Phase
Breast Cancer Procedure: Preoperative sentinel lymph node identification and marking Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 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
Actual Primary Completion Date : November 1, 2012
Actual Study Completion Date : May 10, 2013

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Single arm study - Sentinel Node Localisation 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. ]


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

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


Locations
United Kingdom
Ninewells Hospital and Medical School
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
NHS Tayside
University of Dundee

Responsible Party: Andy Evans, Professor of Breast Imaging, NHS Tayside
ClinicalTrials.gov Identifier: NCT01154972     History of Changes
Other Study ID Numbers: 2010ON03
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018

Keywords provided by Andy Evans, NHS Tayside:
breast
cancer
sentinel lymph node

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