Breast CancerREI-EXCISENCT03432429
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
An observational study of Breast Cancer and Surgery, run by Imperial College London at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery
- What is being tested?
- REIMS iKnife
- How many people
- 158 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 5 Sep 2017to 8 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing breast conserving surgery (BCS) for invasive or non-invasive breast cancer. There is no upper age limit. We believe that older adults represent a group for whom multiple operations could represent a significant perioperative risk and therefore might stand to benefit from iKnife as much if not more so than younger patients. The lower age limit is 18 for the purposes of adequate informed consent to take part in this trial. A breast cancer diagnosis in adolescence is extremely rare.
Who may be able to join
- BCS for ductal carcinoma in situ (B5a)
- BCS for invasive ductal carcinoma (B5b)
- BCS for invasive lobular carcinoma (B5b)
- B3 lesions undergoing surgical excision
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Royal Marsden NHS Foundation Trust (Chelsea)
London, SW3 6JJ
Imperial College NHS Foundation Trust, Charing Cross Hospital
London, W6 8RF
The Royal Marsden NHS Foundation Trust (Sutton)
Sutton, SM2 5PT
About this study
Official title: Rapid Evaporative Ionisation Mass Spectrometry for Examination of Circumferential Surgical Excision Margins
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.
Read the 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.
- Conditions
- Breast Cancer, Surgery
- Being tested
- REIMS iKnife
- Keywords
- Tumours, Breast conserving surgery, Margin assessment technology, Mass spectrometry
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REIMS iKnifeOther
Use of REIMS iKnife in breast conserving surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Secondary outcomes (3)
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.
Measured: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
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.
Measured: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
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.
Measured: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start5 Sep 2017
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, Waters Corporation
- Responsible party
- Sponsor
- Investigators
- Daniel Leff, Principal investigator, Department of Surgery & Cancer, Imperial College LondonZoltan Takats, Principal investigator, Department of Metabolism, Digestion and Reproduction, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03432429
- Sponsor's protocol ID
- 13SM1815
- Other IDs
- 14/EE/0024 (Sub)
- Acronym
- REI-EXCISE
- Status last verified
- Mar 2022
- First submitted
- 17 Nov 2017
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final versions of the anonymised databases and data files will be made available to the wider research community including other groups interested in breast cancer margin technologies and clinical applications / translation of mass spectroscopy. Imperial College London retains copyright of the databases and data files. As part of the registration process users must agree to the conditions in the Data User Agreement including: restrictions against attempting to identify participants; destruction of data after analysis; reporting responsibilities (i.e. any publication arising as a result of sharing of the data will need to acknowledge the project PIs: Zoltan Takats \& Daniel Leff and Cancer Research United Kingdom as the funder); respecting the embargo period regarding publication; proper acknowledgment of the data resource and restrictions on sharing with third parties. A Data User Agreement must be signed before access to the data is permitted.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Evaporative Ionisation Mass Spectrometry for Examination of Circumferential Surgical Excision Margins
- ClinicalTrials.gov ID
- NCT03432429
- Acronym / sponsor ID
- REI-EXCISE / 13SM1815
- Conditions
- Breast Cancer, Surgery
- Keywords
- Tumours, Breast conserving surgery, Margin assessment technology, Mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK, Waters Corporation
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing breast conserving surgery (BCS) for invasive or non-invasive breast cancer. There is no upper age limit. We believe that older adults represent a group for whom multiple operations could represent a significant perioperative risk and therefore might stand to benefit from iKnife as much if not more so than younger patients. The lower age limit is 18 for the purposes of adequate informed consent to take part in this trial. A breast cancer diagnosis in adolescence is extremely rare.
Key inclusion criteria (4 listed)
- BCS for ductal carcinoma in situ (B5a)
- BCS for invasive ductal carcinoma (B5b)
- BCS for invasive lobular carcinoma (B5b)
- B3 lesions undergoing surgical excision
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REIMS iKnifeUse of REIMS iKnife in breast conserving surgery | Other | – |
Primary outcome
Diagnostic accuracy
Time frame: 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.
3 secondary outcomes
Assessment of procedure duration using REIMS
Time frame: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
REIMS technology user satisfaction
Time frame: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Accuracy of predicting oncological status
Time frame: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Yes. Final versions of the anonymised databases and data files will be made available to the wider research community including other groups interested in breast cancer margin technologies and clinical applications / translation of mass spectroscopy. Imperial College London retains copyright of the databases and data files. As part of the registration process users must agree to the conditions in the Data User Agreement including: restrictions against attempting to identify participants; destruction of data after analysis; reporting responsibilities (i.e. any publication arising as a result of sharing of the data will need to acknowledge the project PIs: Zoltan Takats \& Daniel Leff and Cancer Research United Kingdom as the funder); respecting the embargo period regarding publication; proper acknowledgment of the data resource and restrictions on sharing with third parties. A Data User Agreement must be signed before access to the data is permitted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Leff principal investigator
Department of Surgery & Cancer, Imperial College London
Zoltan Takats principal investigator
Department of Metabolism, Digestion and Reproduction, Imperial College London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Imperial College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy (time frame: Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.