Actively Recruiting

FEMALE
NCT06977698

Intra-operative Detection of Positive Margins in Breast Surgery

Led by University of Nottingham · Updated on 2025-05-18

120

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intra-operative Detection of Positive Margins in Breast Surgery

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing breast surgery (wide local excision)
  • Able to give informed consent
  • Any age
Not Eligible

You will not qualify if you...

  • Patients with any doubt regarding the diagnosis from pathologist as confirmed by previous diagnostic biopsy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Nottingham university hospitals

Nottingham, United Kingdom

Actively Recruiting

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Research Team

I

Ioan Notingher

CONTACT

N

Nehal Atallah

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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