Histolog Comparison to Standard Histology

NCT ID: NCT04857229

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2023-12-31

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 surgery.

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 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.

Conditions

Margins of Excision; Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

All patient

All recruited patient will have their margins assessed with the confocal microscope with comparison of accuracy against gold standard histology.

Histolog Scanner

Intervention Type: DEVICE

Confocal Microscope

Interventions

Histolog Scanner

Confocal Microscope

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SamanTree Medical SA

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel R Leff, MBBS FRCS (Gen Surg) MS PhD

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

Imperial College NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

20CX6399

Identifier Type: -

Identifier Source: org_study_id