Breast CancerDiCECTNCT06264934
An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner
An observational study of Breast Cancer and Benign Breast Disease, run by Zedsen Limited at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Benign Breast Disease
- What is being tested?
- Breast scan using the Z-scanner
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions
Who may be able to join
- Attending a symptomatic clinic or other appointment at a participating breast clinic 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 provided informed consent in English
Who cannot join
- Participants who have undergone biopsy less than 14 days before the Z-scanner scan
- Participants with implanted electronics
- 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
Show all 9Show fewer
- Participants with pacemakers
- Participants with open breast wound
- Participants who had previous breast surgery (mastectomy, lumpectomy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Lesley Honeyfield
Adrian Lim
About this study
Official title: An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:
- Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
- Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner.
Read the detailed description
Permittivity is the measure of a material's ability to store electrical energy in the electric field. Different materials are known to have different permittivity including the human body. Research is looking into utilising permittivity differences in the human body to detect cancer. There is a particular focus in breast cancer because it is the most common type of cancer in women globally, and research has shown that permittivity of healthy breast tissue is different to cancer tissue. Furthermore, breast tissue can be easily accessible by non-invasive means and has well-established tools available to support cancer detection. However, results from many studies vary greatly and more research is needed to understand how permittivity can be used in cancer research. Zedsen Limited has developed a permittivity measuring device (Z-scanner) capable of measuring a material's permittivity. The purpose of this study is to establish the permittivity of healthy, benign, and cancer tissue associated with the Z-scanner.
90 women attending a routine screening assessment clinic or a one stop clinic at Charing Cross Hospital will be recruited over the course of a year. The study is split into 2 parts. Part A will recruit 20 participants to assess whether scanner results can be repeated and reproduced by different users and hardware. Part B will recruit 70 participants to assess whether the Z-scanner can differentiate between benign and cancerous lesion. All participants will have both their breasts scanned using the Z-scanner during their routine appointment. This allows us to investigate the ability of the Z-scanner to identify and differentiate benign and cancerous lesions from healthy breast tissue based on permittivity. Results from this study can further our understanding on how permittivity and such devices can be used in cancer research.
- Conditions
- Breast Cancer, Benign Breast Disease
- Being tested
- Breast scan using the Z-scanner
- Keywords
- Breast Cancer, Electrical Capacitance Tomography, Permittivity
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast scan using the Z-scannerDevice
Four repeated scans of both breasts using the Z-scanner.
Breast scan using the Z-scannerDevice
A scan of both breasts using the Z-scanner.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Twenty healthy participants will be recruited to examine the ability of the Z-scanner to identify healthy breast tissue and assess repeatability and reproducibility of the device. Receives: Device: Breast scan using the Z-scanner | |
| Part B | 70 participants (35 benign and 35 malignant) will be recruited to investigate the ability of the Z-scanner to correctly identify and differentiate malignant and/or benign lesions from healthy breast tissue. Receives: Device: Breast scan using the Z-scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of complex permittivity of breast tissue components
Permittivity will be estimated from a series of inter-electrode capacitance derived from raw outputs of the Z-scanner using in house algorithms.
Measured: Jan-Nov 2024
Secondary outcomes (1)
Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)
Measured: Jan-Nov 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start25 Jan 2024
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zedsen Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264934
- Sponsor's protocol ID
- DiCECT
- Acronym
- DiCECT
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into Dielectric Assessment of Permittivity and Cancer in Human Using a Novel Electrical Capacitance Tomography Scanner
- ClinicalTrials.gov ID
- NCT06264934
- Acronym / sponsor ID
- DiCECT / DiCECT
- Conditions
- Breast Cancer, Benign Breast Disease
- Keywords
- Breast Cancer, Electrical Capacitance Tomography, Permittivity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zedsen LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to investigate the ability of a the Z-scanner to identify and differentiate cancer and benign lesions from healthy breast tissue based on permittivity. The main questions it aims to answer are:
- Determine the permittivity values of the Z-scanner associated with healthy, benign, and malignant tissue in human breasts.
- Determine the repeatability, reproducibility, inter-and intra-operator variability of the Z-scanner.
Detailed description
Permittivity is the measure of a material's ability to store electrical energy in the electric field. Different materials are known to have different permittivity including the human body. Research is looking into utilising permittivity differences in the human body to detect cancer. There is a particular focus in breast cancer because it is the most common type of cancer in women globally, and research has shown that permittivity of healthy breast tissue is different to cancer tissue. Furthermore, breast tissue can be easily accessible by non-invasive means and has well-established tools available to support cancer detection. However, results from many studies vary greatly and more research is needed to understand how permittivity can be used in cancer research. Zedsen Limited has developed a permittivity measuring device (Z-scanner) capable of measuring a material's permittivity. The purpose of this study is to establish the permittivity of healthy, benign, and cancer tissue associated with the Z-scanner.
90 women attending a routine screening assessment clinic or a one stop clinic at Charing Cross Hospital will be recruited over the course of a year. The study is split into 2 parts. Part A will recruit 20 participants to assess whether scanner results can be repeated and reproduced by different users and hardware. Part B will recruit 70 participants to assess whether the Z-scanner can differentiate between benign and cancerous lesion. All participants will have both their breasts scanned using the Z-scanner during their routine appointment. This allows us to investigate the ability of the Z-scanner to identify and differentiate benign and cancerous lesions from healthy breast tissue based on permittivity. Results from this study can further our understanding on how permittivity and such devices can be used in cancer research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | – | Device: Breast scan using the Z-scannerTwenty healthy participants will be recruited to examine the ability of the Z-scanner to identify healthy breast tissue and assess repeatability and reproducibility of the device. |
| Part B | – | Device: Breast scan using the Z-scanner70 participants (35 benign and 35 malignant) will be recruited to investigate the ability of the Z-scanner to correctly identify and differentiate malignant and/or benign lesions from healthy breast tissue. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 20 healthy participants 35 participants with benign lesions 35 participants with malignant lesions
Key inclusion criteria (4 listed)
- Attending a symptomatic clinic or other appointment at a participating breast clinic 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 provided informed consent in English
Key exclusion criteria (9 listed)
- Participants who have undergone biopsy less than 14 days before the Z-scanner scan
- Participants with implanted electronics
- Participants with breast implants
- Participants with nipple piercings (unless they are removed prior to the scan)
- Participants who are lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast scan using the Z-scannerFour repeated scans of both breasts using the Z-scanner. | Device | Part A |
| Breast scan using the Z-scannerA scan of both breasts using the Z-scanner. | Device | Part B |
Primary outcome
Measurement of complex permittivity of breast tissue components
Time frame: Jan-Nov 2024
Permittivity will be estimated from a series of inter-electrode capacitance derived from raw outputs of the Z-scanner using in house algorithms.
1 secondary outcome
Permittivity target-to-background contrast ratios for targets of interest (e.g. malignant lesion, benign lesion)
Time frame: Jan-Nov 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Benign Breast Disease, run by Zedsen Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Lin (+44 (0) 7873930941, jessica@zedsen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of complex permittivity of breast tissue components (time frame: Jan-Nov 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.