ICG10
Research type
Research Study
Full title
A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer
IRAS ID
29081
Contact name
Gordon Wishart
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Eudract number
2009-016743-18
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
SLNB is a standard of care in the UK, for axillary staging in early breast cancer. Current standard practice recommends use of both radio-isotope (technetium) and blue dye (patent blue dye) as the most sensitive (>90%)combination to accurately detect the sentinel lymph node(s). Both agents are injected into breast tissue (intradermally and subcutaneously) close to the nipple pre-operatively.
Despite this recommendation, a number of breast units in smaller hospitals have poor access to radio-isotope and are using blue dye alone. There are international shortages of technetium and in early 2009 the radio-isotope was not available for a 2 week period in Cambridge.
We wish to assess a third methodology for SLNB which involves injection of Indocyanine Green (ICG), a green dye that fluoresces in the lymphatics of the breast following intradermal injection. We plan to analyse the sensitivity of ICG for SLNB detection alone and in combination with radio-isotope and/or blue dye.
All patients undergoing SLNB in the Cambridge Breast Unit (CBU) will be eligible to participate in a feasibility study where ICG is injected intradermally along with the other two agents (current standard of care) to observe in how many patients the ICG facilitates detection of the SLN. The fluorescent properties can be seen with a hand-held near infrared camera. We will also evaluate in how many patients the sentinel node(s)can be visualised with axillary ultrasound following injection of ICG.
Based on Japanese data we hope that the use of ICG will in time remove the need for radio-isotope. It is planned to recruit 100 patients over a 12 month period.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
09/H0308/188
Date of REC Opinion
3 Dec 2009
REC opinion
Favourable Opinion