An observational study in Margins of Excision and Breast Cancer, sponsored by Imperial College London. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Imperial College London · Observational
This is a clinical device trial to assess the accuracy of margin assessment for a confocal scanning device (Histolog Scanner) at assessing the margins of breast tissue following wide local excision surgery.
Currently a 15-20% of breast cancer patients have cancer cells seen at the edge of the tissue removed following. 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.
Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient undergoing surgery for breast cancer, who are due to undergo breast conservation surgery. Patient with a diagnosis of invasive breast cancer or DCIS are eligible for recruitment.
Exclusion Criteria:
Patient undergoing mastectomy, including completion mastectomy due to involved margins
All recruited patient will have their margins assessed with the confocal microscope with comparison of accuracy against gold standard histology.
Device: Histolog Scanner
Confocal Microscope
To compare the sensitivity and specificity of involved margins being assessed intra-operatively using Histolog® Scanner system against conventional histology reporting for patient undergoing breast conservation surgery for breast cancer.
To compare the sensitivity and specificity of involved margins being assessed intra-operatively using Histolog® Scanner system against conventional histology reporting for patient undergoing breast conservation surgery for breast cancer.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Imperial College London