Breast Cancer Clinical Trial
Official title:
Rapid Evaporative Ionisation Mass Spectrometry for Examination of Circumferential Surgical Excision Margins
REI-EXCISE is a multicentre, prospective, non-randomised feasibility study, aimed to evaluate the diagnostic accuracy of rapid ionisation mass spectroscopy using an iKnife device. The iKnife will collect vapour, a by-product of surgery, which will pass through the mass spectrometer machine for analysis in order to evaluate what is "normal" and what is "cancerous" breast tissue.
There is an urgent need to address high rates of close or positive margins and re-operative
breast cancer surgery, which commonly results from the inability of the surgeon to rapidly
and reliably evaluate resection margin status intra-operatively.
This study therefore seeks to address this problem by aiming to develop a method for near
real time, in vivo intra-operative tissue classification that may be used by breast surgeons
as an intelligent knife (or "iKnife") to better guide oncological margin control. The method
known as Rapid Evaporative Ionisation Mass Spectrometry (REIMS) technology uses mass
spectrometric and chemometric analysis of the tissue specific ionic content of the surgical
diathermy smoke plume for the rapid identification of dissected breast tissues.
There are no additional treatment interventions as part of REI-EXCISE. The main study
procedures are breast conserving surgery using the REIMS iKnife for mass spectral analysis of
each surgical margin and correlation between the results of a software recognition algorithm
that capitalised on the spectral data (i.e. iKnife margin = positive / negative) with
conventional histopathological assessment. False positive iKnife data will be further
interrogated with digital droplet polymerase chain reaction and imprint cytology assessment.
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