BUBBLE 2012

• Research type

  Research Study

• Full title

  MicroBubble detection and Ultrasound guided Biopsy of axillary Lymph nodes in patients with Early breast cancer.

• IRAS ID

  105774

• Contact name

  Peter Britton

• Sponsor organisation

  Cambridge University Hospitals NHS Foundation Trust

• Eudract number

  2012-001889-14

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  It is important to know whether cancer cells have spread to the lymph nodes (glands) in the axilla (armpit) of patients with newly diagnosed breast cancer. Standard practice is to perform this surgically with sentinel lymph node biopsy (SLNB). Those patients whose nodes contain cancer deposits usually undergo a second operation to remove all their remaining nodes [axillary lymph node dissection (ALND)]. Patients currently undergo axillary ultrasound and needle biopsy of abnormal appearing nodes in an attempt to diagnose lymph node metastases and prevent unnecessary surgical sentinel lymph node biopsy (SLNB). Such techniques are imperfect as there is currently no mechanism to guide the radiologist to the biologically important SLN and biopsy involves sampling with 2-3 small cores of tissue. As a consequence 60% of patients with lymph node metastases currently remain undiagnosed until surgical SLNB is performed (such patients usually require a second operation to remove their remaining nodes). Improving the pre-operative diagnostic rate will require both improved targeting and sampling of the SLN. We propose to inject an ultrasound visible ??dye? (Microbubbles) to find the correct node and once identified to remove the node with a needle. By addressing the twin problems of poor targeting and under-sampling of axillary lymph nodes we hope to substantially increase the pre-operative diagnosis of lymph node involvement and reduce the number of operations patients might require.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  12/EE/0413

• Date of REC Opinion

  24 Sep 2012

• REC opinion

  Favourable Opinion