RecruitingNCT06977698

Intra-operative Detection of Positive Margins in Breast Surgery

Quantitative OCT-Raman Spectral Imaging for Intra-operative Detection of Positive Margins in Breast Conserving Surgery


Sponsor

University of Nottingham

Enrollment

120 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

In this project, we will develop a unique OCT-Raman system based on a selective sampling approach optimised for high-resolution analysis of whole lumpectomy specimens. The aim of using OCT is not to detect the cancer but to identify the adipose tissue, such that the large adipose tissue regions are excluded from any further measurements by Raman spectroscopy. While OCT has a limited ability to distinguish between tumour and surrounding normal stroma, adipose tissue has a distinctive appearance in the OCT images due to low backscattering within adipose cells (filled with lipids and small/flattened nuclei) compared to the highly scattering benign dense tissue (stroma, ducts and lobules) and malignant tissue. Such specific patterns allow identification of normal adipose tissue from breast tissue (classification models based on reflectivity profiles) with 94% sensitivity and 93% specificity. This will reduce the task of Raman measurements, which can be focused on the smaller remaining regions to discriminate between the benign and malignant tissue. This flexible and adaptable scanning strategy will achieve a much-improved diagnosis accuracy and speed to cover all surgical margins within practical timescales.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new technique for detecting whether cancer has been fully removed during breast-conserving surgery (a lumpectomy). The goal is to test whether a new imaging or detection tool used in the operating room can accurately identify if any cancer remains at the edges of the removed tissue. **You may be eligible if...** - You are having breast-conserving surgery (wide local excision / lumpectomy) - You are able to give informed consent - You are any age **You may NOT be eligible if...** - There is any doubt about your cancer diagnosis based on a previous biopsy result Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTOCT-Raman

a machine to detect positive margins in lumpectomy specimens


Locations(1)

Nottingham university hospitals

Nottingham, United Kingdom

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NCT06977698


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