Histolog Comparison to Standard Histology (HiCoSH)

Do the Results of Intra-operative Margin Assessment Correlate With the Output of Conventional Histology for Patient Undergoing Breast Conservation Surgery?

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Margins of Excision
• Intervention / Treatment: Device: Histolog Scanner

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.

• Study Type: Observational
• Enrollment (Actual): 101

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Imperial College NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All patient; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: SamanTree Medical SA

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (ACTUAL): April 23, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20CX6399

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No