Breast Cancer Clinical Trial
— LIESLOfficial 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.
Status | Not yet recruiting |
Enrollment | 994 |
Est. completion date | December 1, 2018 |
Est. primary completion date | November 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Royal Marsden NHS Foundation Trust | Micrima, Ltd. |
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA | Comparison to histopathology result | 1 week (after histopathology result) | |
Primary | 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 | Through study completion, an average of 1 year | |
Primary | 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 | Through study completion, an average of 1 year | |
Secondary | 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 | Through study completion, an average of 1 year | |
Secondary | 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 | Through study completion, an average of 1 year | |
Secondary | Compare the detection of breast cancer from MARIA with the detection from mammography in the overall patient group. | Comparison to Mammography and Pathology result | Through study completion, an average of 1 year | |
Secondary | 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 | After attendance for further imaging, at 1-2 weeks. | |
Secondary | 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. | Through study completion, an average of 1 year | |
Secondary | Patient tolerance of MARIA (a non-compressing, non-ionising modality) | Questionnaire measurement, Quantitative answers. | Through study completion, an average of 1 year |
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