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.
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
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)
Eligible people will be identified from those attending their breast clinic appointment who will be having, or had a mammogram or ultrasound, will be identified by a member of the clinical team. Patients eligible for the NACT sub-study may be identified by two routes: first, participants already enrolled in the main DiTECT study whose malignancy is subsequently confirmed and whose clinical plan is to receive standard-of-care neoadjuvant chemotherapy. Second, patients newly diagnosed with invasive breast cancer at the participating site (including those not previously recruited to the main study) who are identified following routine NHS triple assessment, histological confirmation, multidisciplinary team review, and who are scheduled to commence standard-of-care neo-adjuvant chemotherapy. Those who are eligible for the study will only be approached after the cancer diagnosis at which time they will also receive trial documents.
Cohort
Cross-sectional
TD-BIS scanner
DeviceParticipants will all receive a scan of their breast with the TD-BIS device. This is not an intervention it is an additional non-invasive device with a novel device that is hand-held with non-ionising radiation. The scan with the device will be a research observation which will be performed to test the feasibility and accuracy of the device in this population.
Breast tissue electrical properties
Establish electrical properties of healthy, benign, and malignant tissue associated with the TD-BIS scanner.
Breast density electrical properties
Establish electrical properties of different breast densities reported in Breast-imaging-reporting and Data system (BI-RADS) density category.
Electrical properties of benign and malignant tissues by breast density
Establish electrical properties of benign and malignant tissue in all BI-RADS density category.
Safety of the TD-BIS scanner
Evaluate the safety of the TD-BIS scanner alongside patient tolerability and clinical usability.
Exploratory Outcome: Impact of breast density on lesion identification
Evaluate clinical parameters between benign and malignant tissue and the impact of breast density
Exploratory outcome: Changes in the electrical properties of a malignant lesions
Evaluation of changes in scanner-derived electrical properties following Standard of Care (SOC) intervention for patients receiving Neoadjuvant Chemotherapy (NACT)
Feasibility Outcome: Recruitment feasibility
Establish the research screening and recruitment characteristics to describe feasibility of recruitment related to current eligibility criteria
Feasibility Outcome: Patient experience
Establish the ability to capture patient experience with the TD-BIS scanner using the adapted TMI.
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Zedsen Limited
Lead sponsor
Imperial College Healthcare NHS Trust
Collaborator
