Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Preoperative sentinel lymph node identification and marking

• Registration Number: NCT01154972
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-06-29
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2012-11-01
• Study Completion: 2013-05-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 59

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm study - Sentinel Node Localisation	Preoperative sentinel lymph node identification and marking	-

Primary Outcome Measures

Name	Time	Method
Is the sentinel lymph node marked preoperatively confirmed as the SLN at surgery?	8 Months from start of trial.

Trial Locations

Locations (1)

Ninewells Hospital and Medical School; 🇬🇧 Dundee, United Kingdom