London Investigation Into diElectric Scanning of Lesions

NCT03302819 | Unknown

• 1 other identifier: CCR4702
• Study Type: interventional
• Target: 994
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with breast cancer in whom breast cancer is correctly identified by MARIA

  Comparison to histopathology result

  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

  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

  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.

  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.

  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.

  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.

  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.

  Through study completion, an average of 1 year

Study Arms (3)

Breast cancer accuracy

EXPERIMENTAL

Patients with a known or suspected (and subsequently proven) breast cancer

Diagnostic Test: MARIA scan

Imaging characteristics and performance

EXPERIMENTAL

Patients attending the symptomatic clinic

Diagnostic Test: MARIA scan

Tumour response in neoadjuvant treatment

EXPERIMENTAL

Patients who are being treated with neoadjuvant chemotherapy or endocrine treatment

Diagnostic Test: MARIA scan

Interventions

MARIA scan DIAGNOSTIC_TEST

The patient will have an additional MARIA scan along with conventional imaging, pathology and surgical procedures.

Breast cancer accuracy; Imaging characteristics and performance; Tumour response in neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Attending a symptomatic breast care clinic OR Patients who have a diagnosed or suspected breast cancer (P5/M5/U5/B5).
• Female sex
• years or older.
• Able to provide informed consent.
• Not in any identified, vulnerable group.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Micrima, Ltd.: collaborator

Related Publications (2)

• 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.

  PMID: 27446970 BACKGROUND

• 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.

  PMID: 26442924 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven Allen

  Royal Marsden NHS Foundation Trust

  STUDY CHAIR

• Richard Sidebottom

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Sidebottom

CONTACT

02073528171; richardsidebottom@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: October 5, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share