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

Breast Cancer Clinical Trial

— REI-EXCISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03432429
• Other study ID #: 13SM1815
• Secondary ID: 14/EE/0024 (Sub)
• Status: Completed
• Start date: September 5, 2017
• Est. completion date: December 8, 2021

Study information

• Verified date: March 2022
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: December 8, 2021
• Est. primary completion date: December 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• BCS for ductal carcinoma in situ (B5a)

• BCS for invasive ductal carcinoma (B5b)

• BCS for invasive lobular carcinoma (B5b)

• B3 lesions undergoing surgical excision

Exclusion Criteria:

• Pregnant or lactating

• 18 years or younger

• Diagnostic excision biopsy for classical lobular carcinoma in situ (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)

Note on patients receiving Neo-adjuvant Chemotherapy (NACT):

Patients selecting to receive NACT will be eligible for participation. However, the data for patients receiving NACT will be analysed separately as a pre-planned subgroup and these patients will not contribute data to the n=35 patients with positive margins required for this feasibility trial. Data from NACT cases have not been used to generate the validated multispectral database since eccentric fibrosis made the histological analysis more complex, which limited the number of patients in whom tissue was available for research.

Related Conditions & MeSH terms

• Breast Cancer
• Surgery

Intervention

Other:
• REIMS iKnife
Use of REIMS iKnife in breast conserving surgery

Locations

Country	Name	City	State
United Kingdom	Imperial College NHS Foundation Trust, Charing Cross Hospital	London
United Kingdom	Royal Marsden NHS Foundation Trust (Chelsea)	London
United Kingdom	The Royal Marsden NHS Foundation Trust (Sutton)	Sutton

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Cancer Research UK, Waters Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	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.	Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Secondary	Assessment of procedure duration using REIMS	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.	Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Secondary	REIMS technology user satisfaction	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.	Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Secondary	Accuracy of predicting oncological status	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.	Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.