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

May 11, 2021 updated by: MVG Industries SAS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Galway, Ireland
        • HRB Clinical Research Facility Galway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
  2. Subject must have attended the Symptomatic Breast Unit with a palpable breast lump
  3. Subjects must have had a mammogram in the clinical assessment period (≤ 6 weeks before the microwave breast investigation)
  4. Subjects must be able to comfortably lie reasonably still in a prone position for up to 15 minutes
  5. Subjects with bra size larger than 32B and cup size larger or equal to B.
  6. Subjects whose breast size is adapted to the cylindrical container of the MBI system with sufficient margin to allow the presence of transition liquid around the breast. Final decision to be taken by the physicians based on their judgement.

Exclusion Criteria:

  1. Subjects unable to provide written informed consent
  2. Subjects who are pregnant or breast-feeding
  3. Subjects who have had previous surgery to the breast
  4. Subjects who have previously received chemotherapy or radiotherapy to the breast
  5. Subjects who have had a breast biopsy less than two weeks prior to imaging
  6. Subjects with any active or metallic implant (e.g. cardiac pacemaker, stents, internal cardiac defibrillator, cardiac resynchronisation device, nerve stimulator…), or subjects bearing any non-removable metallic object (e.g. piercing) on their torso
  7. Post-biopsy patients whose breast tissue is not healed sufficiently for the imaging procedure, in the opinion of the investigator
  8. Patients who have had or plan to have a breast cyst aspiration before MBI.
  9. Subjects with significant co-morbidities which, in the opinion of the investigator, may influence the result of the study
  10. Subjects with prior or concurrent malignancy
  11. Subjects under the age of 18 years old
  12. Subjects with evidence of inflammation and/or erythema of the breast as well as any subjects who have a break in the skin which would be in contact with the coupling fluid
  13. Subjects who would be unsuitable for an MBI scan, unlikely to attend a follow up visit, or would otherwise be unsuitable for such an investigation, in the opinion of the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pre-diagnosed breast cancer

Low-power microwave breast imaging system.

Core needle biopsy performed ≥14 days before the microwave breast investigation
Device: Low-power microwave breast imaging system
Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Experimental: Pre-diagnosed breast cyst

Low-power microwave breast imaging system.

No prior biopsy
Device: Low-power microwave breast imaging system
Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
Experimental: Pre-diagnosed benign lesion

Low-power microwave breast imaging system.

Core needle biopsy performed ≥14 days before the microwave breast investigation
Device: Low-power microwave breast imaging system
Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Serious Adverse Events, Directly Related to Normal Functioning of the Device
Time Frame: Through study completion, up to 21 days
To provide early safety information for the proposed investigational medical imaging device.
Through study completion, up to 21 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Duration of study - 19 months
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.
Duration of study - 19 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MVG Industries SAS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
HRB Clinical Research Facility, Galway (CRFG)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Kerin, Prof., Galway University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 7, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TN.32.1.17.SATF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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