Status:
UNKNOWN
Histolog Comparison to Standard Histology
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
SamanTree Medical SA
Conditions:
Margins of Excision
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
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 su...
Detailed Description
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 ar...
Eligibility Criteria
Inclusion
- Patient capable of providing informed consent
- Female
- Have a diagnosis of invasive breast cancer or ductal carcinoma in-situ
- Have been discussed within the multidisciplinary meeting with a recommendation that the patient is suitable for breast conservation therapy
- Any localisation technique can be used of impalpable lesions (eg if the wire impairs the image quality, this will inform for full scale research)
- Patient undergoing breast conservation surgery
- Patient undergoing further breast conservation surgery for positive margins after previous surgery
- Patient's will be able to participate for a re-excision of margin, even if they did not participate for their initial operation
Exclusion
- Patient undergoing mastectomy, including completion mastectomy due to involved margins
- Patients undergoing excision biopsies
- Male patients
- Patients under the age of 18
- Unable to provide valid consent in English language
Key Trial Info
Start Date :
June 4 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04857229
Start Date
June 4 2021
End Date
December 1 2023
Last Update
February 14 2023
Active Locations (1)
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1
Imperial College NHS Trust
London, United Kingdom, W6 8RF