RecruitingNCT06977698

Intra-operative Detection of Positive Margins and Lymph Nodes in Breast Surgery

Multimodal Spectroscopic Imagining for Intra-operative Assessment in Breast Cancer Surgery.


Sponsor

University of Nottingham

Enrollment

120 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

In this project, the investigators will develop novel optical coherence tomography (OCT)-Raman spectroscopy and autofluorescence (AF)-Raman spectroscopy systems based on a selective sampling approach optimised for high-resolution analysis of whole lumpectomy specimens and sentinel lymph node (SLN) biopsies, respectively. The aim of using optical coherence tomography is not to detect cancer directly, but rather to identify adipose tissue so that large adipose regions can be excluded from subsequent Raman spectroscopy measurements. Although OCT has limited ability to distinguish tumour tissue from the surrounding normal stroma, adipose tissue exhibits a distinctive appearance in optical coherence tomography images because of its low backscattering properties, resulting from adipocytes that are filled with lipids and contain small, flattened nuclei. In contrast, benign dense tissue (stroma, ducts, and lobules) and malignant tissue produce much stronger backscattering signals. These characteristic patterns enable adipose tissue to be distinguished from other breast tissues using classification models based on optical coherence tomography reflectivity profiles, achieving 94% sensitivity and 93% specificity. Excluding adipose tissue from further analysis reduces the number of Raman spectroscopy measurements required, allowing the remaining, smaller tissue regions to be examined to discriminate between benign and malignant tissue. This flexible and adaptable scanning strategy is expected to improve both diagnostic accuracy and scanning speed, enabling complete assessment of surgical margins within clinically practical timescales. In addition, the investigators will develop a novel (AF)-Raman spectroscopy system based on a selective sampling approach optimised for high-resolution analysis of sentinel lymph node specimens. The purpose of incorporating autofluorescence imaging is to identify the optimal sampling locations for subsequent Raman spectroscopy measurements, thereby improving the efficiency of tissue interrogation while maintaining diagnostic accuracy.


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

DIAGNOSTIC_TESTAF-Raman

a machine for detection sentinel lymph nodes in Breast conserving surgery.


Locations(1)

Nottingham university hospitals

Nottingham, United Kingdom

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NCT06977698


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