Histolog Comparison to Standard Histology

NCT04857229 | Unknown

• 1 other identifier: 20CX6399
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Margins of Excision; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Histolog Scanner DEVICE

Confocal Microscope

All patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• SamanTree Medical SA: collaborator

Study Sites (1)

Imperial College NHS Trust

London, W6 8RF, United Kingdom

Location

MeSH Terms

Conditions

Margins of Excision; Breast Neoplasms

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

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

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 23, 2021
• Study Start: June 4, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)