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Low-power microwave breast imaging system.

Core needle biopsy performed ≥14 days before the microwave breast investigation

Low-power microwave breast imaging system.

No prior biopsy

Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump

Low-power microwave breast imaging system

Michael Kerin, Prof.

The trialed investigational medical imaging device is a low-power microwave breast imaging system for cancer screening purposes. It is an active device which uses non-ionizing radiation.

Microwave imaging is an emerging imaging modality for the early detection of the breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at microwave frequencies. Microwave imaging can potentially be used for monitoring neoadjuvant chemotherapy treatment, breast health monitoring, and for routine screening and diagnosis of the breast cancer at the early-stage. The non-invasive and the non-ionizing characteristics of microwaves should allow for frequent scans of the breast using microwave imaging, unlike X-ray mammography. In addition to safety, microwave imaging does not require uncomfortable breast compression and it is potentially a lower-cost modality.

This is a first-in-human clinical test of the investigational device, which has been so far tested only with experimental phantoms modelling the human female breast.

The clinical data that will be collected in the context of this study is intended to provide early safety information for the investigational medical imaging device. In addition, this exploratory data will guide the refinement of the device hardware and the imaging algorithm design, before decision to proceed (or not) with further clinical tests.

Furthermore, this study will be used to guide sample size calculation for a subsequent study designed to evaluate efficacy should that appear warranted once this study is completed.

This is a single-site early-phase pilot clinical study, taking place at Galway University Hospital/HRB Clinical Research Facility, Galway.

Patients will have a conventional history and breast examinations (Mammogram and / or Ultrasound and Clinical assessment) performed by the physician, as per normal practice in the Symptomatic Breast Unit of University Hospital Galway.

If patients are interested in the study, provide written informed consent and are deemed eligible, they will attend the Clinical Research Facility Galway for a Microwave Breast Imaging (MBI) scan. The data from the scan will be collected and stored securely. Patients will be followed up 7-21 days after the microwave breast investigation or before surgery, whichever comes first. Patients will be assessed for their experience of the microwave breast investigation, and for any adverse events.

The investigational medical imaging device consists of two subsystems, both performing a non-invasive examination:

* the Microwave Breast Imaging subsystem (MBI subsystem);
* the Optical Breast Contour Detection subsystem (OBCD subsystem);

The MBI subsystem is an active device which uses non-ionizing radiation. It illuminates the breast with low-power electromagnetic waves in the microwave frequency spectrum, which penetrate the breast under examination. The subsystem collects the scattered electromagnetic waves and recovers useful information on the breast tissue consistency, given the dielectric contrast of these tissues.

Multi-static radar detection technology is employed in the MBI subsystem for breast image formation.The well-established Microwave Vision Group (MVG) technology for fast antenna measurement, using multiple sensors in a vertical arch configuration, has been transposed to a horizontal arch of sensors. In addition, vertical translation of the horizontal arch has been enabled, such that 3D multi-static short-range radar imaging is possible.

The sensors are in contact with a cylindrical container filled with a liquid; the so-called coupling liquid has been designed to have electromagnetic (EM) properties appropriately selected such that the EM wave penetration in the breast is maximized.

During the MBI scan, the patient is lying in a face down position on a special bed, integrated with the MBI subsystem. The breast under examination is immersed in the coupling liquid, through a dedicated circular opening of the bed. The breast is then scanned. This vertical scan takes approximately 10-15 minutes to complete, depending on the size of each breast.

In order to compute the required volume of coupling liquid, such that the container of the MBI subsystem is optimally filled after immersion of the breast, a simple process for optical assessment of the total volume of the breast takes place just before starting the MBI scan.

The Optical Breast Contour Detection (OBCD) subsystem serves to provide the total volume of the breast, and also its external contour, as a priori information to the MBI subsystem. The OBCD subsystem consists of a 3D optical camera placed below the examination table, at a distance of several tens of centimetres below the breast. An azimuthal scan of the 3D camera permits to reconstruct the external surface of the breast.

In order for the breast contour to be a useful a priori information for the MBI subsystem, it is important that the patient is lying in the same face down position during both the MBI and OBCD scans. Thus, an identical examination table, as the one integrated with the MBI subsystem, is also integrated with the OBCD subsystem. During the OBCD scan, the patient is lying on the examination table, with her breast under examination inserted in the circular opening of the examination table. For this scan, there is no coupling liquid; the breast is in the air, hanging below the examination table.

Both the breast bearing the palpable lump and the contralateral breast will be scanned. The contralateral breast scan will serve as control in the data analysis.

The MBI scan duration of each breast should not exceed 15 minutes. The recorded data will be checked and in the case of non-optimal positioning of the patient, the scan may be repeated.

It is expected that the duration of the microwave breast investigation (including OBCD scan of both breasts for breast volume assessment, preparation of the MBI subsystem, MBI scan of both breasts, and data verification) should not exceed 1 hour. If the Data Quality Check suggests repetition of the MBI scan, and upon agreement by the patient, the total duration of the microwave breast investigation will be extended.

The written radiology reports from conventional imaging will be acquired and used to evaluate the performance of the MBI subsystem in terms of detecting and estimating the size and consistency of the breast lump.

MBI data analysis will be performed off-line, at MVG premises (France), and is expected to be completed few months after the end-date of data collection. Following the assessment of the MBI results by the medical experts involved in the study, a decision will be made regarding the potential of this emerging imaging modality and the interest in proceeding with clinical studies involving larger sample sizes. Based on these results, MVG will decide and plan actions for refinement of the system, towards an upgraded version to be used for potential future tests with a more significant impact.

The study is performed on 3 groups of patients:

* Group 1: 15 patients with pre-diagnosed breast cancer (core needle biopsy performed ≥14 days before the microwave breast investigation).
* Group 2: 10 patients with breast cyst. No prior biopsy
* Group 3: 5 patients with pre-diagnosed benign lesion (core needle biopsy performed ≥14 days before the microwave breast investigation).

Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.

Pilot Clinical Evaluation of a Microwave Imaging System for Early Breast Cancer Detection

Percentage of total number of biopsy-confirmed malignant breast lesions being detected with MBI; Percentage of total number of pre-diagnosed breast cysts being detected with MBI; Percentage of total number of biopsy-confirmed benign breast lesions being detected with MBI.

To provide early safety information for the proposed investigational medical imaging device.

HRB Clinical Research Facility, Galway (CRFG)

MVG Industries SAS

Low-power microwave breast imaging system.

Core needle biopsy performed ≥14 days before the microwave breast investigation

Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump

Pre-diagnosed Breast Cancer - Biopsy Confirmed

Low-power microwave breast imaging system.

No prior biopsy

Low-power microwave breast imaging system: Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump

Pre-diagnosed Breast Cyst

Pre-diagnosed Benign Lesion - Biopsy Confirmed

Total

Age, Continuous

Sex: Female, Male

Race

Race/Ethnicity, Customized

Ireland

Region of Enrollment

The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Volumetric Breast Density (VBD) with the Volpara VDM software.

VBD was computed on both breasts of each patient (total number of samples = 40).

Volumetric Breast Density

The "For processing" DICOM mammography data was unavailable for four (4) of the twenty-four (24) analysed patients due to accidental deletion/retention of data. This data is required to compute the Breast Volume with the Volpara VDM software.

The volume of both breasts of each patient was computed (total number of samples = 40).

Breast Volume

Overall, there have been twenty-five (25) patients scanned with the low-power Microwave Breast Imaging (MBI) system. Out of the twenty-five (25) patients, twenty-four (24) were included in the final analysis. The patient who was excluded from the final analysis was a patient who presented with a palpable lump which was subsequently determined to be normal breast tissue

First in Human, exploratory, open clinical study was conducted in order to gather clinical data to support refinement of Prototype # 1 of the low-power MBI system as well as initial safety information

Luc Duchesne

All patients who had a low-power Microwave Breast Imaging (MBI) scan completed

Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device

Capacity of the Low-power Microwave Breast Imaging (MBI) System to Detect Pre-diagnosed Palpable Breast Lesions. Detection Rate for Malignant and Benign Breast Lesions.

Overall Study

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Inflammation

Communicable Diseases

Mastitis

Lipoma

Women without a diagnosis of cancer or a history of cancer.

Lizzy van Thillo, AA

Carrie Bomarito, RN

David A Benaron, MD

The purposes of this study is to establish normal optical values of breast tissue in the general population. This will allow for establishing normals for breast composition, and is expected to be useful in the classification of breast lesions into groups such as cysts, benign growths, inflammatory lesions, and possibly early breast cancer.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Clinical Study on a Low-power Electromagnetic Wave Breast Imaging Device for Cancer Screening Purposes.	NCT03475992	Breast Cancer Breast Cyst	Low-power micro...	18 Years -	MVG Industries SAS
Survey of Optical Values of the Breast Using Radiation-Free Pressure-Free Optical Scanning	NCT00671385	Breast Lesions Breast Cyst Early-Stage Bre... Benign Growth, ...		21 Years - 50 Years	Spectros Corporation

Spots Global Cancer Trial Database for breast cyst

Every month we try and update this database with for breast cyst cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for breast cyst

Every month we try and update this database with for breast cyst cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for breast cyst cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.