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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Patients undergoing breast surgery (wide local excision).

• Able to give informed consent.

• Any age.

Locations
Other Locations
United Kingdom
Nottingham university hospitals
RECRUITING
Nottingham
Contact Information
Primary
Ioan Notingher
ppzin@exmail.nottingham.ac.uk
0)115 951 3082
Backup
Nehal Atallah
msznma@nottingham.ac.uk
07521100084
Time Frame
Start Date: 2023-10-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 120
Related Therapeutic Areas
Sponsors
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov