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There are currently no widely accepted methods which provide real time in vivo, in situ tissue diagnostics within the operating theatre environment.
This project proposes that the oncological nature of in vivo tissue may be accurately identified using mass spectrometric analysis of tissue specific ions released during thermal degradation of tissue as occurs during electrosurgery.
Subsequently, the protocol describes a technique for a prospective study to determine whether Rapid Evaporative Ionisation Mass Spectrometry (REIMS) can be used to accurately identify the nature of human tissue both ex vivo and in vivo.
The project aims/objectives comprise the following:
The following will be collected from each enrolled participant:
Custom built Mass spectrometers will be installed at participating sites. Optimal electrosurgical settings, in terms of obtaining maximal amount of good quality spectral data whilst providing adequate surgical dissection, will be determined between operating surgeons and researchers.
All spectral data collected will be uploaded anonymised into a research database with the full histology provided. The spectra will be pre-processed according to the mass spectrometer used for collection.
In addition to diagnostic accuracy REIMS offers additional advantages to existing and emerging IMA techniques. Specifically, the REIMS iKnife allows use of a standard operating procedure without altering operative workflow in that the technique samples the surgical aerosol already being generated during excision. The rapid time frame of analysis to results (1-2 seconds) means that eventually surgeons' decision-making may be altered in real-time to achieve negative margins or improve patient prognosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapid Evaporative Ionisation Mass Spectrometry (REIMS) | Other | Use of iKnife instrument during standard operative practice |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of spectral data | To determine whether Rapid Evaporative Ionisation Mass Spectrometry (REIMS) can be used to accurately discern between cancerous and normal tissue both in vivo and ex vivo | 10 years |
| Margin Analysis | The primary end-point is 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. | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tumour margin analysis | The primary end-point is 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. | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing resectional surgery or gastrointestinal endocoscopic procedures.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adele Savage | Contact | a.savage@imperial.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Zoltan Takats | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | Enrolling by invitation | London | SW7 2AZ | United Kingdom | ||
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Fresh ex vivo tissue samples for mass spectral (MS) analysis and histological examination where applicable (may be retained for long term storage and may be used in subsequent research including genetic testing, subject to having ethical approval)
| St. Mary's Hospital |
| Recruiting |
| London |
| United Kingdom |
|