Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Use of REIMS iKnife in breast conserving surgery

REIMS iKnife

Daniel Leff

Zoltan Takats

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.

Resected tissue samples will undergo detailed histopathological examination using a standard reporting schema based on the Royal College of Pathologists guidelines for breast specimen processing and the results of the histological examination of the tissue along the electrosurgical dissection line will be compared to the results of mass spectrometric tissue identification.

Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study

Rapid Evaporative Ionisation Mass Spectrometry for Examination of Circumferential Surgical Excision Margins

Final versions of the anonymised databases and data files will be made available to the wider research community including other groups interested in breast cancer margin technologies and clinical applications / translation of mass spectroscopy.

Imperial College London retains copyright of the databases and data files. As part of the registration process users must agree to the conditions in the Data User Agreement including: restrictions against attempting to identify participants; destruction of data after analysis; reporting responsibilities (i.e. any publication arising as a result of sharing of the data will need to acknowledge the project PIs: Zoltan Takats \& Daniel Leff and Cancer Research United Kingdom as the funder); respecting the embargo period regarding publication; proper acknowledgment of the data resource and restrictions on sharing with third parties. A Data User Agreement must be signed before access to the data is permitted.

The diagnostic accuracy of rapid ionisation mass spectroscopy for oncological margin status will be measured during breast conserving surgery (BCS) (n=35 patients with positive margins). The primary end-point will allow to report accuracy (sensitivity and specify) of rapid ionisation mass spectroscopy to distinguish between patients with at least one close or positive margin and those without close or positive margin.

This study will quantify whether REIMS adds significantly to the intra-operative time taken to perform breast conserving surgery. Thus, the data generated with REI-EXCISE trial will report the difference in specimen excision time using iKnife as compared to conventional electrosurgery.

This study will be collecting data to understand if end-users are sufficiently satisfied with REIMS technology framework (including modified hand-piece) , and are willing to use it routinely during breast conserving surgery (BCS). This will be conveyed by analysing the end user questionnaire completed by the surgeons to infer if they are satisfied with the use of REIMS instrumentation in vivo to perform BCS.

The intra-operative REIMS analysis will be used to accurately predict/measure the oncological status of the surface of the wide local excision cavity. The data will be reported as the proportion of patients with all close or positive margins correctly detected as positive by iKnife and as the proportion of patients with no margin malignancy correctly detected by iKnife among the true negative patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study	NCT03432429	Breast Cancer Surgery	REIMS iKnife	18 Years -	Imperial College London
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study	NCT03432429	Breast Cancer Surgery	REIMS iKnife	18 Years -	Imperial College London

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