London Investigation Into diElectric Scanning of Lesions (LIESL)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MARIA scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Breast cancer accuracy
Imaging characteristics and performance
Tumour response in neoadjuvant treatment
Arm Description
Patients with a known or suspected (and subsequently proven) breast cancer
Patients attending the symptomatic clinic
Patients who are being treated with neoadjuvant chemotherapy or endocrine treatment
Outcomes
Primary Outcome Measures
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
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.
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.
Comparison of response to surgical histology
Secondary Outcome Measures
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
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
Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group.
Comparison to Mammography and Pathology result
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
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.
Patient tolerance of MARIA (a non-compressing, non-ionising modality)
Questionnaire measurement, Quantitative answers.
Full Information
NCT ID
NCT03302819
First Posted
September 21, 2017
Last Updated
October 4, 2017
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Micrima, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03302819
Brief Title
London Investigation Into diElectric Scanning of Lesions
Acronym
LIESL
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Anticipated)
Primary Completion Date
November 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Micrima, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
994 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Breast cancer accuracy
Arm Type
Experimental
Arm Description
Patients with a known or suspected (and subsequently proven) breast cancer
Arm Title
Imaging characteristics and performance
Arm Type
Experimental
Arm Description
Patients attending the symptomatic clinic
Arm Title
Tumour response in neoadjuvant treatment
Arm Type
Experimental
Arm Description
Patients who are being treated with neoadjuvant chemotherapy or endocrine treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
MARIA scan
Intervention Description
The patient will have an additional MARIA scan along with conventional imaging, pathology and surgical procedures.
Primary Outcome Measure Information:
Title
Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA
Description
Comparison to histopathology result
Time Frame
1 week (after histopathology result)
Title
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.
Description
Comparison with clinical, radiology and pathology findings
Time Frame
Through study completion, an average of 1 year
Title
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.
Description
Comparison of response to surgical histology
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Compare the detection of breast cancer from MARIA with the detection from mammography by the sub-group of histology type.
Description
Comparison to Mammography and Pathology result
Time Frame
Through study completion, an average of 1 year
Title
Compare the detection of breast cancer from MARIA with the detection from mammography by sub-group of mammographic density.
Description
Comparison to Mammography and Pathology result
Time Frame
Through study completion, an average of 1 year
Title
Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group.
Description
Comparison to Mammography and Pathology result
Time Frame
Through study completion, an average of 1 year
Title
Assessment of data repeatability (test re-test) of MARIA assessment results on patients with diagnostic follow-up imaging.
Description
Comparison with prior MARIA scan when returning for further imaging
Time Frame
After attendance for further imaging, at 1-2 weeks.
Title
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.
Description
The correlation between the pathological features of the lesion and the imaging features as determined from MARIA including presence of features, shape and size.
Time Frame
Through study completion, an average of 1 year
Title
Patient tolerance of MARIA (a non-compressing, non-ionising modality)
Description
Questionnaire measurement, Quantitative answers.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Sidebottom
Phone
02073528171
Ext
1407
Email
richardsidebottom@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Allen
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard Sidebottom
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27446970
Citation
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.
Results Reference
background
PubMed Identifier
26442924
Citation
Saadatmand 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.
Results Reference
background
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London Investigation Into diElectric Scanning of Lesions
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