Breast cancer screening using a new time-domain bioimpedance device
Official title: An Investigation Into Dielectric Testing for the Evaluation and Characterisation of Breast Tissue Using a Novel Time-Domain Bioimpedance Tool
Run by Zedsen Limited · NCT07782814 · Data updated 2026-11-12
This study tests whether a new TD-BIS scanner can help distinguish healthy breast tissue from cancerous or benign lesions in women during clinical visits.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | Women only |
| Enrollment | 220 (estimated) |
| Sponsor | Zedsen Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | September 2028 |
| Study ends | December 2028 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07782814 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older attending a participating breast clinic, who are fluent in English and consent, including those eligible for the NACT sub-study.
✕Probably not a fit
Individuals with recent biopsy, implants, pacemakers, prior breast surgery, or other disqualifying conditions may not benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the breath-by-breath electrical properties of breast tissue using the TD-BIS scanner. It aims to identify signatures that differentiate cancerous or benign changes from normal tissue, and to understand how breast density affects detection. The device comprises a Sensor Head, Charging Cradle, and a computer-guided App to standardize data collection during scans. Previous work suggested the device can identify lesions, with accuracy varying by breast density; this study expands to a larger, more diverse cohort. Participants include women attending breast clinics who consent to the scan and, for a subset, potential integration with neoadjuvant therapy data.
Why it matters
Potential benefit: If successful, this approach could lead to a less invasive tool to aid breast lesion detection.
How similar studies have gone: Preliminary UK work showed the TD-BIS scanner could differentiate some lesion types, but performance depended on breast density; broader validation is needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Imperial College Trust
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Adrian Lim, MD FRCP FRCR — Imperial College NHS Trust
- Study coordinator: Rosalynn Austin, PhD, RN, BN, MSc, BSc
- Email: rosalynn@zedsen.com
- Phone: +447531785361
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.