NCT07782814 An Investigation Into Dielectric Testing for the Evaluation and Characterisation of Breast Tissue Using a Novel Time-Domain Bioimpedance Tool

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 220 participants in total. It began in 2026-09-30 with a primary completion date of 2028-09.

Brief Summary

Capacitance measures a material's ability to store the movement of electrical energy in the electric field. Different of the human body are known to have different capacitance values. Research is looking into utilising capacitance differences, using a method called bioimpedance, to detect signatures of cancer. Breast cancer is the most common type of cancer in women globally, and the bioimpedance of healthy breast tissue is different to cancer tissue. Breast tissue is accessible by non-invasive means and has well-established clinical tools for cancer detection. However, results from studies vary and research is needed to understand how bioimpedance can be used in cancer research and the development of less invasive detection tools. Zedsen Limited developed the time-domain bioimpedance sensing (TD-BIS) scanner capable of measuring capacitance. Previous versions of the TD-BIS scanner were investigated in a proof-of-concept study and shown to be safe to use. The proposed study aims to establish the feasibility, safety, and performance of the updated TD-BIS scanner in classifying healthy, benign, and cancer tissue. We will recruit 220 women attending a breast appointment at Charing Cross Hospital (40 without lesions, and 90 with malignant lesions and 90 with benign lesions). Invited women will have their breasts scanned after routine imaging and before any biopsy. Data will be fed into AI algorithms to enhance the TD-BIS scanner performance. The TD-BIS scanner's ability to measure capacitance of tumours that are being treated with neoadjuvant chemotherapy will be explored. Twenty women with a malignancy who consent to being followed up over their treatment course, will have 2 additional scans. Finally, participants will be asked to share their experience of the TD-BIS scanner in a questionnaire. Results from this study can further our understanding on how capacitance and such devices can be used in breast cancer clinical management.

Eligibility Criteria

Inclusion Criteria: * Attending a breast clinic appointment or other appointment at a participating site * Assigned female sex at time of birth * Aged 18 years or older at time of scan * Willing, able and mentally competent to read, understand, and provide informed consent in English * Patients who wish to enter the NACT sub-study, inclusion in NACT care is required. Exclusion Criteria: * Participants who have undergone biopsy less than 14 days before the TD-BIS scanner session * Participants with implanted electronics anywhere in the body * Participants with breast implants * Participants with nipple piercings (unless they are removed prior to the scan) * Participants who are lactating * Pregnant participants by verbal confirmation * Participants with pacemakers * Participants with open breast wound * Participants who had previous breast surgery (mastectomy, lumpectomy) * Participants who have breast lesion localisation device (i.e., wire, seed, Magseed) \*Patients who wish to enter the NACT sub-study, there is one additional exclusion criteria: * Participants who have any breast surgery prior to the second scan

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