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

ConditionBreast Cancer Invasive

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

AgeNot listed

SponsorUniversity of Nottingham

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing breast surgery wide local excision (WLE).

Able to give informed consent.

Any age.

Disqualifiers

None

Trial population

Patients undergoing Wide Local Excision (WLE) for breast cancer at the Breast Cancer Institute, Nottingham City Hospital.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

OCT-Raman
Diagnostic test
a machine to detect positive margins in lumpectomy specimens
AF-Raman
Diagnostic test
a machine for detection sentinel lymph nodes in Breast conserving surgery.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Design and build unique OCT and AF-Raman system with integrated machine learning algorithms.

To design and develop OCT-Raman and AF-Raman imaging systems, including their hardware and software architectures with integrated machine learning algorithms, and install both prototypes at UON for evaluation. The OCT-Raman system will be used to distinguish cancerous from normal breast tissue in lumpectomy and mastectomy specimens, while the AF-Raman system will be used to distinguish metastatic lymph nodes from normal lymphoid tissue. In each study, tissue samples will be scanned independently, and the measured area will be recorded in mm² for each specimen. Average Raman spectral intensities will then be calculated separately for cancerous and normal tissues, and a t-test will be performed to identify the Raman bands exhibiting the most significant differences between the two tissue types. Data acquisition, area measurements, and statistical analyses for the two experiments will be conducted independently by separate investigators.

Time frame

12 months

Secondary outcomes

Feasibility and Diagnostic Performance of Intraoperative Raman Spectroscopy

Secondary endpoint is the assembly of the Raman devices in the clinical intraoperative theatre for a quick and reliable measures of wide local excisions and lymph node specimens within short period of time (10-20 minutes). The desired end point will be detecting cancer cells with both sensitivity and specificity higher than 95%.

Time frame

30 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Source ClinicalTrials.gov

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