Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

NCT ID: NCT01154972

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-05-10

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single arm study - Sentinel Node Localisation

Group Type: EXPERIMENTAL

Preoperative sentinel lymph node identification and marking

Intervention Type: PROCEDURE

SLN is identified using gamma probe and ultrasound. Percutaneous wire placement carried out to mark SLN for subsequent surgical verification.

Interventions

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.

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: collaborator

NHS Tayside

OTHER_GOV

Sponsor Role: lead

Responsible Party

Andy Evans

Professor of Breast Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ninewells Hospital and Medical School

Dundee, , United Kingdom

Countries

United Kingdom

Other Identifiers

2010ON03

Identifier Type: -

Identifier Source: org_study_id