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

NCT07782814 | Not Yet Recruiting

• 4 other identifiers: ZED-DiTECT-PROT-001IRAS 37021426/EE/0128CI-2026-0035-GB
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast - Female

Keywords

Cancer Screening; Breast Screening; Breast Tissue; Capacitance; Breast Density; Medical Device

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Breast density electrical properties

  Enrollment to end of study, anticipated to be 24 months.

• Electrical properties of benign and malignant tissues by breast density

  Enrollment to end of study, anticipated to be 24 months.

• Safety of the TD-BIS scanner

  Enrollment to end of study, anticipated to be 24 months.

Other Outcomes (4)

• Exploratory Outcome: Impact of breast density on lesion identification

  Enrollment to end of study, anticipated to be 24 months.

• Exploratory outcome: Changes in the electrical properties of a malignant lesions

  Enrollment to end of study, anticipated to be 24 months.

• Feasibility Outcome: Recruitment feasibility

  Enrollment to end of study, anticipated to be 24 months.

Study Arms (4)

Benign Lesions

Participants with clinically identified benign lesions

Device: TD-BIS scanner

Malignant Lesions

Participants with clinically identified malignant lesions

Device: TD-BIS scanner

No Lesions

Participants with no clinically identified lesions

Device: TD-BIS scanner

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

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.

Benign Lesions; Malignant Lesions; NACT sub-study; No Lesions

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)
• Participants who have any breast surgery prior to the second scan

Sponsors & Collaborators

• Zedsen Limited: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Trust

London, W6 8RF, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 41663830 BACKGROUND

• 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.

  PMID: 29651637 BACKGROUND

• 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.

  PMID: 32373777 BACKGROUND

• 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.

  PMID: 18190724 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Marc Goldfinger, PhD

  Zedsen Limited

  STUDY DIRECTOR

• Adrian Lim, MD FRCP FRCR

  Imperial College NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalynn Austin, PhD, RN, BN, MSc, BSc

CONTACT

+447531785361; rosalynn@zedsen.com

Marc Goldfinger, PhD

CONTACT

+447531785361; marc@zedsen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)