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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Breast - Female
• Intervention / Treatment: Device: TD-BIS scanner

Detailed Description

Zedsen Limited has manufactured a TD-BIS scanner, which can measure electrical properties of different human tissue types. The equipment consists of two operational parts: a Charging Cradle and a Sensor Head. The Sensor Head is used to perform measurements on a client's breast. The Charging Cradle is used to charge and hold the Sensor Head between and after measurements, as well as to enable data transfer. A computerised system runs the TD-BIS scanner's associated Application (App) will guide the clinical user on completing the breast scan to ensure complete data collection.

The TD-BIS scanner capable of measuring electrical properties of breast tissue. A preliminary study in the UK evidenced the TD-BIS scanner's ability to identify lesions from healthy breast tissue based on differences in tissue electrical properties. In the proof-of-concept study, the TD-BIS scanner was able to identify invasive lesion, in situ lesions and benign breast changes (including cysts, AIDEP and fibroadenoma) ranging in size from as small as 0.5cm3 to larger than 1.5cm3. Further, the accuracy of lesion detection was impaired in breasts with higher density (BI-RAD scores C and D) . The proposed study aims to further investigate and validate previous results by utilising the TD-BIS scanner on a larger, more diverse cohort of patients and while exploring the effects of breast density on lesion detection.

Breast density is the amount of fibroglandular tissue compared with the amount of fatty tissue in the breast . Breast density if currently classified using a mammogram (MMG) according to the 4-point BI-RADS breast density category: A, entirely fatty; B, scattered areas of fibroglandular density; C, heterogeneously dense; D, extremely dense. Higher breast density (BI-RADS category of C or D) is a known risk factor for breast cancer .

MMG is the gold standard imaging modality used in breast cancer screening and diagnosis . While it contributes to increased survival rates of breast cancer patients through early detection, it has many limitations including exposure to ionising radiation, patient discomfort, and most notably, a decreased sensitivity in dense breasts. Just under half of all women, particularly those who are younger, pre- or perimenopausal or women of colour; have more dense breasts. Other imaging modalities such as Magnetic Resonance Imaging (MRI) and ultrasound are less affected by breast density but are limited by other factors such as accessibility, costs, semi-quantitative results and high false positive rates.

Dielectric imaging is emerging as a promising technique for breast cancer detection. As a principle it uses differences in electric properties called capacitance, specifically permittivity and conductivity, which measure any materials ability to store of move energy. There are cellular differences between breast tissue types (no-lesion, benign or malignant lesions) which has been shown to have an impact on the bioelectric properties. There is some evidence to suggest that this way of imaging a breast may also overcome some of the MMG limitations of detecting breast tissue types, within dense breasts. But these systems still require specialist equipment within hospitals.

Further, the existing method used to evaluate tumour response to neoadjuvant chemotherapy, is subjective. The response evaluation criteria in solid tumours (RECIST) 1.1 is the standard method used. It requires an experienced radiologist to choose the target lesions and measure changes in tumour size before and after treatment. The methods is limited due to inherent variability and errors in reported related to clinical efficacy, as well as only capturing size differences with no way to capture the change in tumour microstructure that occurs with effective treatment.

The prototype TD-BIS scanner was shown to capture the bioelectric signal of various types of breast tissue types in the first-in-human study. The prototype device has been refined in collaboration with clinical users and the proposed study will now invite a larger population of women who are attending a breast health clinic to be scanned with the TD-BIS scanner in addition to their standard of care breast health clinic appointment. Clinicians and patients will be blinded to the TD-BIS scanner outputs, and their clinical findings and results will be used as the ground truth.

The aim of the study is to determine the feasibility of using the improved TD-BIS scanner to identify the electrical properties of various breast tissues types. It will also be evaluated for its ability to classify breast density, differentiate lesion type, and the safety and tolerability of the device in a UK clinical population.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Rosalynn Austin, PhD, RN, BN, MSc, BSc; Phone Number: +447531785361; Email: rosalynn@zedsen.com
• Study Contact Backup: Name: Marc Goldfinger, PhD; Phone Number: +447531785361; Email: marc@zedsen.com

Study Locations

• United Kingdom
  • London, United Kingdom, W6 8RF
    • Imperial College Trust
    • Contact: Adrian Lim, Professor and Consultant Radiologist, MD FRCP FRCR; Phone Number: +4420 3313 0764; Email: adrian.lim@nhs.net
    • Sub-Investigator: Farah Rehman, MBBS
    • Sub-Investigator: Lesley Honeyfield, BA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Benign Lesions; Participants with clinically identified benign lesions	Device: TD-BIS scanner; 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.
Malignant Lesions; Participants with clinically identified malignant lesions	Device: TD-BIS scanner; 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.
No Lesions; Participants with no clinically identified lesions	Device: TD-BIS scanner; 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.
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).	Device: TD-BIS scanner; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast tissue electrical properties	Establish electrical properties of healthy, benign, and malignant tissue associated with the TD-BIS scanner.	Enrollment to the end of the study, anticipated to be 24 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast density electrical properties	Establish electrical properties of different breast densities reported in Breast-imaging-reporting and Data system (BI-RADS) density category.	Enrollment to end of study, anticipated to be 24 months.
Electrical properties of benign and malignant tissues by breast density	Establish electrical properties of benign and malignant tissue in all BI-RADS density category.	Enrollment to end of study, anticipated to be 24 months.
Safety of the TD-BIS scanner	Evaluate the safety of the TD-BIS scanner alongside patient tolerability and clinical usability.	Enrollment to end of study, anticipated to be 24 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Outcome: Impact of breast density on lesion identification	Evaluate clinical parameters between benign and malignant tissue and the impact of breast density	Enrollment to end of study, anticipated to be 24 months.
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)	Enrollment to end of study, anticipated to be 24 months.
Feasibility Outcome: Recruitment feasibility	Establish the research screening and recruitment characteristics to describe feasibility of recruitment related to current eligibility criteria	Enrollment to end of study, anticipated to be 24 months.
Feasibility Outcome: Patient experience	Establish the ability to capture patient experience with the TD-BIS scanner using the adapted TMI.	Enrollment to end of study, anticipated to be 24 months.

Collaborators and Investigators

• Sponsor: Zedsen Limited
• Collaborators: Imperial College Healthcare NHS Trust
• Investigators: Study Director: Marc Goldfinger, PhD, Zedsen Limited; Principal Investigator: Adrian Lim, MD FRCP FRCR, Imperial College NHS Trust

Publications and helpful links

General Publications

• Vachon CM, van Gils CH, Sellers TA, Ghosh K, Pruthi S, Brandt KR, Pankratz VS. Mammographic density, breast cancer risk and risk prediction. Breast Cancer Res. 2007;9(6):217. doi: 10.1186/bcr1829.
• Beaumont H, Cantini L, Saini KS, Faye N, Gill R, Iannessi A. What are RECIST 1.1 progressions made of? Variability in double-read oncology trials. Eur Radiol. 2026 Jul;36(7):6159-6169. doi: 10.1007/s00330-025-12234-4. Epub 2026 Feb 9.
• Nazari SS, Mukherjee P. An overview of mammographic density and its association with breast cancer. Breast Cancer. 2018 May;25(3):259-267. doi: 10.1007/s12282-018-0857-5. Epub 2018 Apr 12.
• Moore JX, Han Y, Appleton C, Colditz G, Toriola AT. Determinants of Mammographic Breast Density by Race Among a Large Screening Population. JNCI Cancer Spectr. 2020 Feb 26;4(2):pkaa010. doi: 10.1093/jncics/pkaa010. eCollection 2020 Apr.

Helpful Links

• Website of the Medtech company who created the device used in this study

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: August 17, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 24, 2026

Study Record Updates

• Last Update Posted (Actual): August 27, 2026
• Last Update Submitted That Met QC Criteria: August 24, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Medical Device; Breast Screening; Breast Density; Breast Tissue; Cancer Screening; Capacitance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: ZED-DiTECT-PROT-001; IRAS 370214 (Other Identifier: Health Research Authority (HRA)); 26/EE/0128 (Other Identifier: East of England - Cambridge East Research Ethics Committee); CI-2026-0035-GB (Other Identifier: Medicines and Healthcare Products Regulatory Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant consent for widespread and open sharing of data was not part of the ethical review and approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No