HiCoSH (Histolog Comparison to Standard Histology)
Research type
Research Study
Full title
Do the results of intra-operative margin assessment correlate with the output of conventional histology for patient undergoing breast conservation surgery?
IRAS ID
289272
Contact name
Daniel Leff
Contact email
Sponsor organisation
Imperial College
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Currently a 15-20% of breast cancer patients have cancer cells seen at the end of the tissue removed following surgery. These patient will need to undergo a second operation to ensure all the cancer cells are removed, which has psychological, cosmetic and cost implications. Several technologies have been designed to allow the edges of tissue to be tested during surgery, with the most accurate being those that involve assessing the tissue edge at a cellular level. However, these techniques are time consuming which makes their use in routine work impractical.
The Histolog system uses pinhole (confocal) microscopy to capture cellular level images of the edge of tissue intra-operatively. The first generation of the device has been shown to be accurate for assessing breast tissue biopsies and skin cancer. The second generation of the device has an 8cm plate for scanning tissue and is CE marked for the assessment of tissue margins. This project is to show that the device is accurate for the assessment of margins, with further assessment in relation to the time for images to be captured and ease of interpretation to assess overall feasibility.
The study would recruit at a single high volume breast cancer centre. The study will recruit patients with a diagnosis of breast cancer who are due to undergo breast conservation surgery (lumpectomy) with inclusion criteria of female patients over the age of 18 who are able to give informed consent.
The study would involve the edges of removed tissue being imaged following surgery. These images would be reported by a consultant histopathologist and compared to the routine gold standard histology. There is no change to patient care and the device will not be used to change the surgery performed. There are no questionnaires or additional demands placed on the participants.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0487
Date of REC Opinion
31 Dec 2020
REC opinion
Favourable Opinion