Clinical trial · Observational
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Rapid Evaporative Ionisation Mass Spectrometry for Examination of Circumferential Surgical Excision Margins
NCT03432429CI-TRIAL-00057477REI-EXCISEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| REIMS iKnife | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic accuracy
- timeFrame
- Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
- description
- 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 outcomes (3)
- measure
- Assessment of procedure duration using REIMS
- timeFrame
- Data collected during recruitment period: 1st June 2017 until 31st May 2019 i.e. 24 months.
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * BCS for ductal carcinoma in situ (B5a) * BCS for invasive ductal carcinoma (B5b) * BCS for invasive lobular carcinoma (B5b) * B3 lesions undergoing surgical excision Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.