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Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Preoperative sentinel lymph node identification and marking
Sponsored by
NHS Tayside
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring breast, cancer, sentinel lymph node

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ninewells Hospital and Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study - Sentinel Node Localisation

Arm Description

Outcomes

Primary Outcome Measures

Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?

Secondary Outcome Measures

Full Information

First Posted
June 29, 2010
Last Updated
May 7, 2018
Sponsor
NHS Tayside
Collaborators
University of Dundee
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1. Study Identification

Unique Protocol Identification Number
NCT01154972
Brief Title
Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer
Official Title
Preoperative Identification of the Sentinel Lymph Node in Breast Cancer, Using Ultrasound and Radio-isotope/Percutaneous Gamma Probe
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
November 1, 2012 (Actual)
Study Completion Date
May 10, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Tayside
Collaborators
University of Dundee

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast, cancer, sentinel lymph node

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm study - Sentinel Node Localisation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Preoperative sentinel lymph node identification and marking
Intervention Description
SLN is identified using gamma probe and ultrasound. Percutaneous wire placement carried out to mark SLN for subsequent surgical verification.
Primary Outcome Measure Information:
Title
Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?
Time Frame
8 Months from start of trial.

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Ninewells Hospital and Medical School
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

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