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

NCT03432429 | Completed

• 2 other identifiers: 13SM181514/EE/0024 (Sub)
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 3

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.

Conditions

Breast Cancer; Surgery

Keywords

Tumours; Breast conserving surgery; Margin assessment technology; Mass spectrometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Assessment of procedure duration using REIMS

  Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.

• REIMS technology user satisfaction

  Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.

• Accuracy of predicting oncological status

  Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.

Interventions

REIMS iKnife OTHER

Use of REIMS iKnife in breast conserving surgery

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• BCS for ductal carcinoma in situ (B5a)
• BCS for invasive ductal carcinoma (B5b)
• BCS for invasive lobular carcinoma (B5b)
• B3 lesions undergoing surgical excision

You may not qualify if:

• Pregnant or lactating
• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Cancer Research UK: collaborator
• Waters Corporation: collaborator

Study Sites (3)

Royal Marsden NHS Foundation Trust (Chelsea)

London, SW3 6JJ, United Kingdom

Location

Imperial College NHS Foundation Trust, Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

The Royal Marsden NHS Foundation Trust (Sutton)

Sutton, SM2 5PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Resected tissue samples will undergo detailed histopathological examination using a standard reporting schema based on the Royal College of Pathologists guidelines for breast specimen processing and the results of the histological examination of the tissue along the electrosurgical dissection line will be compared to the results of mass spectrometric tissue identification.

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daniel Leff

  Department of Surgery & Cancer, Imperial College London

  PRINCIPAL INVESTIGATOR

• Zoltan Takats

  Department of Metabolism, Digestion and Reproduction, Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2017
• First Posted: February 14, 2018
• Study Start: September 5, 2017
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after study completion
• Access Criteria: Researchers will be able to access data upon a written request to the project PIs (Zoltan Takats \& Daniel Leff).

Locations

GB (3)