Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed 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.
Study Design
Outcome Measures
Primary Outcome Measures
- Diagnostic accuracy [Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.]
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.
Secondary Outcome Measures
- Assessment of procedure duration using REIMS [Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.]
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.
- REIMS technology user satisfaction [Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.]
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.
- Accuracy of predicting oncological status [Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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BCS for ductal carcinoma in situ (B5a)
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BCS for invasive ductal carcinoma (B5b)
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BCS for invasive lobular carcinoma (B5b)
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B3 lesions undergoing surgical excision
Exclusion Criteria:
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Pregnant or lactating
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18 years or younger
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Marsden NHS Foundation Trust (Chelsea) | London | United Kingdom | SW3 6JJ | |
| 2 | Imperial College NHS Foundation Trust, Charing Cross Hospital | London | United Kingdom | W6 8RF | |
| 3 | The Royal Marsden NHS Foundation Trust (Sutton) | Sutton | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Imperial College London
- Cancer Research UK
- Waters Corporation
Investigators
- Principal Investigator: Daniel Leff, Department of Surgery & Cancer, Imperial College London
- Principal Investigator: Zoltan Takats, Department of Metabolism, Digestion and Reproduction, Imperial College London
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13SM1815
- 14/EE/0024 (Sub)