Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

NCT01154972 | Completed

• 1 other identifier: 2010ON03
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

breast; cancer; sentinel lymph node

Outcome Measures

Primary Outcomes (1)

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

  8 Months from start of trial.

Study Arms (1)

Single arm study - Sentinel Node Localisation

EXPERIMENTAL

Procedure: Preoperative sentinel lymph node identification and marking

Interventions

Preoperative sentinel lymph node identification and marking PROCEDURE

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

Single arm study - Sentinel Node Localisation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NHS Tayside: lead
• University of Dundee: collaborator

Study Sites (1)

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Breast Imaging

Study Record Dates

• First Submitted: June 29, 2010
• First Posted: July 1, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: May 10, 2013
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

GB (1)