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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Imperial College Trust
RECRUITING
London
Contact Information
Primary
Rosalynn Austin, PhD, RN, BN, MSc, BSc
rosalynn@zedsen.com
+447531785361
Backup
Marc Goldfinger, PhD
marc@zedsen.com
+447531785361
Time Frame
Start Date: 2026-09-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 220
Treatments
Benign Lesions
Participants with clinically identified benign lesions
Malignant Lesions
Participants with clinically identified malignant lesions
No Lesions
Participants with no clinically identified lesions
NACT sub-study
Participants from the malignant lesion cohort who agree to additional TD-BIS scanner sessions during their NACT treatment (pre-, mid-, and post- treatment).
Related Therapeutic Areas
Sponsors
Collaborators: Imperial College Healthcare NHS Trust
Leads: Zedsen Limited

This content was sourced from clinicaltrials.gov