Status:
COMPLETED
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Cancer Research UK
Waters Corporation
Conditions:
Breast Cancer
Surgery
Eligibility:
FEMALE
18+ years
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 coll...
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 eval...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 5 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 8 2021
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT03432429
Start Date
September 5 2017
End Date
December 8 2021
Last Update
March 31 2022
Active Locations (3)
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1
Royal Marsden NHS Foundation Trust (Chelsea)
London, United Kingdom, SW3 6JJ
2
Imperial College NHS Foundation Trust, Charing Cross Hospital
London, United Kingdom, W6 8RF
3
The Royal Marsden NHS Foundation Trust (Sutton)
Sutton, United Kingdom, SM2 5PT