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Completed

NCT Number: NCT01154972

Preoperative Localisation of the Sentinel Lymph Node in Breast Cancer

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ninewells Hospital and Medical School

Dundee, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 8 Months from start of trial.

Sponsors and collaborators

Lead sponsor

NHS Tayside

Other Gov

Collaborators

  • University of Dundee

Registry information

Official study title

Preoperative Identification of the Sentinel Lymph Node in Breast Cancer, Using Ultrasound and Radio-isotope/Percutaneous Gamma Probe

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Jul 1, 2010
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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