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iKnife REIMS Project (iKnife)

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ClinicalTrials.gov Identifier: NCT04067388
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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.


Condition or disease Intervention/treatment
Neoplasms Neoplasm Malignant Other: Rapid Evaporative Ionisation Mass Spectrometry (REIMS)

Detailed Description:

The project aims/objectives comprise the following:

  1. Building of histologically validated spectral databases for normal, benign and malignant tissue using ex vivo tissue analysis by Rapid Evaporative Ionisation Mass Spectrometry (REIMS).
  2. Optimisation of a technique to provide accurate, real-time information on the nature of tissue intra-operatively using Rapid Evaporative Ionisation Mass Spectrometry.
  3. Optimisation of a technique to provide accurate, real-time information on the nature of tissue during endoscopic procedures using Rapid Evaporative Ionisation Mass Spectrometry.
  4. In vivo testing of the accuracy of the technique using pre-built spectral databases both intraoperatively and during endoscopic procedures including, but not limited to, the use of sub-study trials.
  5. Validation of spectral data obtained using a second mass spectral analysis technique, Desorption Electrospray Ionisation Mass Spectrometry (DESI).
  6. Bacterial identification from tissue using mass spectrometry, standard microbiology culture and metagenomic sequencing by '454 pyrosequencing.

The following will be collected from each enrolled participant:

  1. Fresh ex vivo tissue samples for mass spectral (MS) analysis and histological examination where applicable
  2. In vivo MS data from surgical diathermy smoke collected intra-operatively.

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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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Time Tissue Characterisation Using Mass Spectrometry
Actual Study Start Date : May 2014
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Intervention Details:
  • Other: Rapid Evaporative Ionisation Mass Spectrometry (REIMS)
    Use of iKnife instrument during standard operative practice


Primary Outcome Measures :
  1. Analysis of spectral data [ Time Frame: 10 years ]
    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

  2. Margin Analysis [ Time Frame: 10 years ]
    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.


Secondary Outcome Measures :
  1. Tumour margin analysis [ Time Frame: 10 years ]
    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.


Biospecimen Retention:   Samples With DNA
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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing resectional surgery or gastrointestinal endocoscopic procedures.
Criteria

Inclusion Criteria:

  • Patients over the age of 18
  • Patients who are able to provide informed consent
  • Patients undergoing screening, endoscopy or surgical resection of tissue

Exclusion Criteria:

  • All patients under the age of 18 years
  • All patients who are pregnant
  • Patients who are unable to provide informed consent or who do not wish to be included in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067388


Contacts
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Contact: Adele Savage a.savage@imperial.ac.uk

Locations
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United Kingdom
Imperial College London Enrolling by invitation
London, United Kingdom, SW7 2AZ
St. Mary's Hospital Recruiting
London, United Kingdom
Contact: James Kinross       J.kinross@imperial.ac.uk   
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Zoltan Takats Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04067388    
Other Study ID Numbers: 124247
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
iKnife
Mass sprectronomy
Additional relevant MeSH terms:
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Neoplasms