REI-EXCISE

Overview

Positive tumour resection margins following attempted breast conserving surgery (BCS) is one of the most important contributing risk factors for ipsilateral local recurrence. It is recommended that in cases where margins are positive or “close” that further surgery is carried out to confirm that margins are clear of disease.

Re-operative breast cancer surgery has physical, psychological and economic sequelae. It may result in delays to receipt of adjuvant therapy and has been associated with an elevated risk of local and distant disease relapse.

REI-EXCISE is a Cancer Research UK funded, multicentre, prospective, non-randomised intra-operative feasibility study, designed to determine the diagnostic accuracy of rapid ionisation mass spectroscopy for oncological margin status determination during breast conserving surgery towards the development of an intelligent knife (iKnife) for improved margin control and reduced re-operative interventions.

There are NO additional treatment interventions as part of REI-EXCISE. The main study procedures are BCS 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 with conventional histopathological assessment.

Objectives

Primary Objective

• To determine the diagnostic accuracy of rapid ionisation mass spectroscopy for oncological margin status determination during breast conserving surgery.

Secondary Objective

• To clarify whether REIMS adds significantly to the intra-operative time taken to perform BCS.
• To determine if end-users are sufficiently satisfied with REIMS technology framework (including modified hand-piece) as to be willing to use it routinely during BCS.
• To establish whether margin status as determined by intra-operative REIMS analysis will accurately predict the oncological status of the surface of the wide local excision cavity.

Inclusion criteria

Patients will be eligible for this trial if they are undergoing:

• BCS for ductal carcinoma in situ (B5a)
• BCS for invasive ductal carcinoma (B5b)
• BCS for invasive lobular carcinoma (B5b)

Exclusion criteria

We will exclude patients from entering this study if they are:

• Pregnant or lactating
• 16 years or younger
• Diagnostic excision biopsy for classical LCIS (current practice is that classical LCIS at a surgical resection margin would not mandate wider excision) or if the patient is diagnosed with Non-epithelial breast tumour (phyllodes, lymphoma)