Breast CancerLIESLNCT03302819
London Investigation Into diElectric Scanning of Lesions
A study testing MARIA scan in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust.
Trial summary
The MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The performance and imaging characteristics of MARIA are not yet well demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MARIA scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 994 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2017to 1 Dec 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending a symptomatic breast care clinic OR Patients who have a diagnosed or suspected breast cancer (P5/M5/U5/B5).
- Female sex
- 18 years or older.
- Able to provide informed consent.
- Not in any identified, vulnerable group.
Who cannot join
- Unable to mount MARIA™ patient bed using provided 2-step
- Unable to lie in the prone position
- Patients who have undergone biopsy less than 5 days before the MARIA™ scan
- Patients with implanted electronics.
- Patients with breast implants.
- Patients with nipple piercings (unless they are removed prior to the MARIA™ scan)
- Breast sizes smaller than 197ml or greater than 1L in volume
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Performance Evaluation of the MARIA (Multi Static Array Processing of Radiowave Image Acquisition) Radar Breast Imaging System in Patients With Breast Cancer and in Patients Assessed in the Symptomatic Breast Clinic.
The MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The performance and imaging characteristics of MARIA are not yet well demonstrated. The investigators aim to evaluate some aspects of this potentially important new technology.
Read the detailed description
The early diagnosis of breast cancer is of paramount importance, with a 5-year survival rate of 97% if the cancer is caught "locally", deteriorating to 79% if it has progressed to the "axillary" lymph nodes, and 23% if it has spread to the rest of the body, known as "metastasised."
Diagnosis is currently achieved through clinical examination, imaging with mammography (MMG) and/or ultrasound (US) and needle biopsy. Mammography is dependent upon adequate breast compression to allow greater contrast differentiation between tissue structures, this is not only uncomfortable, but in younger women with 'dense' breast tissue the contrast difference between normal tissue and tumour is minimal despite compression. Furthermore mammography uses ionising radiation, which means that a risk/benefit calculation is weighted against repeated or frequent use. Frequently it is necessary to use additional imaging such as ultrasound or MRI for diagnostic support.
Breast tumours have an additional property that can distinguish them from normal and this is defined by the dielectric value. This has two components - the dielectric constant, which affects the velocity of propagation of radio waves and therefore their wavelength, and the conductivity, which affects the rate of attenuation. Typically a tumour has a dielectric constant of 45-50 and a conductivity of 2S/m, whereas breast fat is 5-15 and 0.2-1S/m respectively but with considerable range. Normal glandular tissue is intermediate. These differences in dielectric constant enable a consideration of the value of this data in breast cancer diagnosis.
Several attempts to exploit this property for imaging have been made. The outcomes have been similar in that the presence of a tumour is detectable, however limitations in depth for detection and mode of the technology were identified.
Due to updated technology in the MARIA device, previous limitations from similar studies are not reported to be a problem.
This study aims to determine the proportion of patients with breast cancer who are correctly diagnosed by MARIA, and to stratify this by breast density and histological type. In addition a pilot study will be performed to investigate the imaging characteristics and performance of MARIA in the assessment of benign and malignant lesions in patients attending the symptomatic breast clinic.
The MARIA scan will be in addition to any standard diagnostic procedures, including imaging, that comprise the standard of care. The scan will require them to lie prone for less than 10 minutes with their breast pendant in an ergonomically-fitted bowl with a thin layer of a coupling fluid (similar to hand moisture in consistency) applied to the surface of the breast.
While there is no direct benefit nor detrimental effect from this study to the patients participating, the study has large implications for many women.
This study will allow the investigators to test the feasibility of this highly innovating approach to breast cancer, with minimal negative effects or possible complications. This diagnostic modality could prove to be a major step forwards in cancer detection, initially as a complementary source of information that can increase confidence in results obtained from established technologies that are routinely deployed in the clinic.
- Conditions
- Breast Cancer
- Being tested
- MARIA scan
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIA scanDiagnostic test
The patient will have an additional MARIA scan along with conventional imaging, pathology and surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer accuracy | Experimental | Patients with a known or suspected (and subsequently proven) breast cancer Receives: Diagnostic Test: MARIA scan |
| Imaging characteristics and performance | Experimental | Patients attending the symptomatic clinic Receives: Diagnostic Test: MARIA scan |
| Tumour response in neoadjuvant treatment | Experimental | Patients who are being treated with neoadjuvant chemotherapy or endocrine treatment Receives: Diagnostic Test: MARIA scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
Comparison to histopathology result
Measured: 1 week (after histopathology result)
Sensitivity and specificity of MARIA for a range of findings to include, simple cysts, fibroadenomata, and malignant lesions. As judged against the final diagnosis at discharge, which may be based on clinical findings, imaging and pathology data.
Comparison with clinical, radiology and pathology findings
Measured: Through study completion, an average of 1 year
Proportion of post-operative patients treated with neo-adjuvant chemotherapy or endocrine therapy, correctly identified by MARIA with complete response or residual disease, as compared to surgical histology.
Comparison of response to surgical histology
Measured: Through study completion, an average of 1 year
Secondary outcomes (6)
Compare the detection of breast cancer from MARIA with the detection from mammography by the sub-group of histology type.
Comparison to Mammography and Pathology result
Measured: Through study completion, an average of 1 year
Compare the detection of breast cancer from MARIA with the detection from mammography by sub-group of mammographic density.
Comparison to Mammography and Pathology result
Measured: Through study completion, an average of 1 year
Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group.
Comparison to Mammography and Pathology result
Measured: Through study completion, an average of 1 year
Assessment of data repeatability (test re-test) of MARIA assessment results on patients with diagnostic follow-up imaging.
Comparison with prior MARIA scan when returning for further imaging
Measured: After attendance for further imaging, at 1-2 weeks.
Investigate the performance of MARIA in the estimation of residual tumour size compared to the final surgical histology results in the case of patients receiving neo-adjuvant chemotherapy or endocrine therapy.
The correlation between the pathological features of the lesion and the imaging features as determined from MARIA including presence of features, shape and size.
Measured: Through study completion, an average of 1 year
Patient tolerance of MARIA (a non-compressing, non-ionising modality)
Questionnaire measurement, Quantitative answers.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Nov 2018 (estimated)
- Study completion1 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 994 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Micrima, Ltd.
- Responsible party
- Sponsor
- Investigators
- Steven Allen, Study chair, Royal Marsden NHS Foundation TrustRichard Sidebottom, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302819
- Sponsor's protocol ID
- CCR4702
- Acronym
- LIESL
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Preece AW, Craddock I, Shere M, Jones L, Winton HL. MARIA M4: clinical evaluation of a prototype ultrawideband radar scanner for breast cancer detection. J Med Imaging (Bellingham). 2016 Jul;3(3):033502. doi: 10.1117/1.JMI.3.3.033502. Epub 2016 Jul 20.
PubMed 27446970Saadatmand S, Bretveld R, Siesling S, Tilanus-Linthorst MM. Influence of tumour stage at breast cancer detection on survival in modern times: population based study in 173,797 patients. BMJ. 2015 Oct 6;351:h4901. doi: 10.1136/bmj.h4901.
PubMed 26442924
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the MARIA (Multi Static Array Processing of Radiowave Image Acquisition) Radar Breast Imaging System in Patients With Breast Cancer and in Patients Assessed in the Symptomatic Breast Clinic.
- ClinicalTrials.gov ID
- NCT03302819
- Acronym / sponsor ID
- LIESL / CCR4702
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 994 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Micrima, Ltd.
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Nov 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 5 Oct 2017 (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 MARIA breast imaging system is a novel CE-marked radio-frequency (RF) medical imaging device. The system employs an electromagnetic imaging technique that exploits the dielectric contrast between normal and cancerous tissues. The performance and imaging characteristics of MARIA are not yet well demonstrated. The investigators aim to evaluate some aspects of this potentially important new technology.
Detailed description
The early diagnosis of breast cancer is of paramount importance, with a 5-year survival rate of 97% if the cancer is caught "locally", deteriorating to 79% if it has progressed to the "axillary" lymph nodes, and 23% if it has spread to the rest of the body, known as "metastasised."
Diagnosis is currently achieved through clinical examination, imaging with mammography (MMG) and/or ultrasound (US) and needle biopsy. Mammography is dependent upon adequate breast compression to allow greater contrast differentiation between tissue structures, this is not only uncomfortable, but in younger women with 'dense' breast tissue the contrast difference between normal tissue and tumour is minimal despite compression. Furthermore mammography uses ionising radiation, which means that a risk/benefit calculation is weighted against repeated or frequent use. Frequently it is necessary to use additional imaging such as ultrasound or MRI for diagnostic support.
Breast tumours have an additional property that can distinguish them from normal and this is defined by the dielectric value. This has two components - the dielectric constant, which affects the velocity of propagation of radio waves and therefore their wavelength, and the conductivity, which affects the rate of attenuation. Typically a tumour has a dielectric constant of 45-50 and a conductivity of 2S/m, whereas breast fat is 5-15 and 0.2-1S/m respectively but with considerable range. Normal glandular tissue is intermediate. These differences in dielectric constant enable a consideration of the value of this data in breast cancer diagnosis.
Several attempts to exploit this property for imaging have been made. The outcomes have been similar in that the presence of a tumour is detectable, however limitations in depth for detection and mode of the technology were identified.
Due to updated technology in the MARIA device, previous limitations from similar studies are not reported to be a problem.
This study aims to determine the proportion of patients with breast cancer who are correctly diagnosed by MARIA, and to stratify this by breast density and histological type. In addition a pilot study will be performed to investigate the imaging characteristics and performance of MARIA in the assessment of benign and malignant lesions in patients attending the symptomatic breast clinic.
The MARIA scan will be in addition to any standard diagnostic procedures, including imaging, that comprise the standard of care. The scan will require them to lie prone for less than 10 minutes with their breast pendant in an ergonomically-fitted bowl with a thin layer of a coupling fluid (similar to hand moisture in consistency) applied to the surface of the breast.
While there is no direct benefit nor detrimental effect from this study to the patients participating, the study has large implications for many women.
This study will allow the investigators to test the feasibility of this highly innovating approach to breast cancer, with minimal negative effects or possible complications. This diagnostic modality could prove to be a major step forwards in cancer detection, initially as a complementary source of information that can increase confidence in results obtained from established technologies that are routinely deployed in the clinic.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer accuracy | Experimental | Diagnostic Test: MARIA scanPatients with a known or suspected (and subsequently proven) breast cancer |
| Imaging characteristics and performance | Experimental | Diagnostic Test: MARIA scanPatients attending the symptomatic clinic |
| Tumour response in neoadjuvant treatment | Experimental | Diagnostic Test: MARIA scanPatients who are being treated with neoadjuvant chemotherapy or endocrine treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Attending a symptomatic breast care clinic OR Patients who have a diagnosed or suspected breast cancer (P5/M5/U5/B5).
- Female sex
- 18 years or older.
- Able to provide informed consent.
- Not in any identified, vulnerable group.
Key exclusion criteria (7 listed)
- Unable to mount MARIA™ patient bed using provided 2-step
- Unable to lie in the prone position
- Patients who have undergone biopsy less than 5 days before the MARIA™ scan
- Patients with implanted electronics.
- Patients with breast implants.
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 |
|---|---|---|
| MARIA scanThe patient will have an additional MARIA scan along with conventional imaging, pathology and surgical procedures. | Diagnostic test | Breast cancer accuracy, Imaging characteristics and performance, Tumour response in neoadjuvant treatment |
Primary outcome
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
Time frame: 1 week (after histopathology result)
Comparison to histopathology result
Sensitivity and specificity of MARIA for a range of findings to include, simple cysts, fibroadenomata, and malignant lesions. As judged against the final diagnosis at discharge, which may be based on clinical findings, imaging and pathology data.
Time frame: Through study completion, an average of 1 year
Comparison with clinical, radiology and pathology findings
Proportion of post-operative patients treated with neo-adjuvant chemotherapy or endocrine therapy, correctly identified by MARIA with complete response or residual disease, as compared to surgical histology.
Time frame: Through study completion, an average of 1 year
Comparison of response to surgical histology
6 secondary outcomes
Compare the detection of breast cancer from MARIA with the detection from mammography by the sub-group of histology type.
Time frame: Through study completion, an average of 1 year
Compare the detection of breast cancer from MARIA with the detection from mammography by sub-group of mammographic density.
Time frame: Through study completion, an average of 1 year
Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group.
Time frame: Through study completion, an average of 1 year
Assessment of data repeatability (test re-test) of MARIA assessment results on patients with diagnostic follow-up imaging.
Time frame: After attendance for further imaging, at 1-2 weeks.
Investigate the performance of MARIA in the estimation of residual tumour size compared to the final surgical histology results in the case of patients receiving neo-adjuvant chemotherapy or endocrine therapy.
Time frame: Through study completion, an average of 1 year
Patient tolerance of MARIA (a non-compressing, non-ionising modality)
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Background: PubMed 27446970Preece AW, Craddock I, Shere M, Jones L, Winton HL. MARIA M4: clinical evaluation of a prototype ultrawideband radar scanner for breast cancer detection. J Med Imaging (Bellingham). 2016 Jul;3(3):033502. doi: 10.1117/1.JMI.3.3.033502. Epub 2016 Jul 20.
- Background: PubMed 26442924Saadatmand S, Bretveld R, Siesling S, Tilanus-Linthorst MM. Influence of tumour stage at breast cancer detection on survival in modern times: population based study in 173,797 patients. BMJ. 2015 Oct 6;351:h4901. doi: 10.1136/bmj.h4901.
- 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.
Steven Allen study chair
Royal Marsden NHS Foundation Trust
Richard Sidebottom principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing MARIA scan in people with Breast Cancer, run by Royal Marsden NHS Foundation Trust.
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 5 inclusion and 7 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 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Richard Sidebottom (02073528171 ext. 1407, richardsidebottom@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA (time frame: 1 week (after histopathology result)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03302819, which also lists 2 linked publications.
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 5 Oct 2017.