Feasibility of indocyanine green in sentinel node biopsy in melanoma

• Research type

  Research Study

• Full title

  Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The "RED-GREEN-BLUE" melanoma study.

• IRAS ID

  105887

• Contact name

  Marc Moncrieff

• Sponsor organisation

  Norfolk & Norwich University Hospital NHS Foundation Trust

• Eudract number

  2012-002244-25

• ISRCTN Number

  n/a

• Research summary

  Sentinel lymph node biopsy is a standard of care for staging in stage I & II melanoma. Current standard practice recommends use of both radioðisotope (technetium) and blue dye (patent blue dye) as the most sensitive (>95%) combination to accurately detect the sentinel lymph node(s). Both agents are injected into intradermally directly adjacent to the melanoma scar. Scanning for sentinel nodes is technically challenging to perform and requires highly skilled nuclear medicine technicians to successfully and accurately undertake it. Lymphatic drainage of the skin is extremely varied and aberrant or interval lymph nodes can be easily overlooked. Furthermore, there are international shortages of technetium and in early 2009 the radioðisotope was not available for a 2 week period. We wish to assess a third methodology for SLNB detection which involves injection of Indocyanine Green (ICG), a green dye thafluresces in the lymphatics of the sub-dermis following intradermal injection. We plan to analyse the sensitivity of ICG for SLNB detection alone and in combination with radioðisotope and blue dye. All patients undergoing SLNB in the Norfolk & Norwich Skin Tumour Unit will be eligible to participate in a feasibility study where ICG is injected intradermally along with technetium and blue dye (current standard of care) to observe in how many patients the ICG facilitates detection of the SLN. Thflurescent properties can be seen with a handðheld near infrared camera. Based on work elsewhere, it may be that the use of ICG will in time remove the need for radioðisotope. It is planned to recruit up to 60 patients over a 6-month period.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  12/YH/0295

• Date of REC Opinion

  29 Jun 2012

• REC opinion

  Further Information Favourable Opinion