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

Sponsor
Zedsen Limited
Study ID
NCT07782814
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • TD-BIS scanner — DEVICE
    Participants 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.

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
220 participants (estimated)

Arms

  • Arm: Benign Lesions
    Participants with clinically identified benign lesions
  • Arm: Malignant Lesions
    Participants with clinically identified malignant lesions
  • Arm: No Lesions
    Participants with no clinically identified lesions
  • Arm: 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).

Primary Outcome Measure

Breast tissue electrical properties [ Time Frame: Enrollment to the end of the study, anticipated to be 24 months. ]

Central Contacts

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