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

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ClinicalTrials.gov Identifier: NCT03475992
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
HRB Clinical Research Facility, Galway (CRFG)
Information provided by (Responsible Party):
MVG Industries SAS

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cyst Device: Low-power microwave breast imaging system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The study is performed on 3 groups of patients:

  • Group 1: 15 patients with pre-diagnosed breast cancer (core needle biopsy performed at least 2 weeks 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 at least 2 weeks before the microwave breast investigation).
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Clinical Evaluation of a Microwave Imaging System for Early Breast Cancer Detection
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pre-diagnosed breast cancer

Low-power microwave breast imaging system.

Core needle biopsy performed at least 2 weeks 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 at least 2 weeks 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




Primary Outcome Measures :
  1. Number of Serious Adverse Events, directly related to normal functioning of the device [ Time Frame: Through study completion, an average of 9 months ]
    Safety assessment of the investigational medical device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be able and willing to give written informed consent and to comply with the requirements of the study protocol
  2. Presenting to 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. The subject's breast size should be such that the patient wears a bra cup in the range: 34A -36DD.

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 within the past two weeks
  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. Subjects with significant co-morbidities which, in the opinion of the investigator, may influence the result of the study.
  9. Subjects with prior or concurrent malignancy.
  10. Subjects under the age of 18 years old.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475992


Contacts
Contact: Luc Duchesne, Msc 0033169298156 luc.duchesne@mvg-world.com
Contact: Angie Fasoula, PhD 0033169298152 angie.fasoula@mvg-world.com

Locations
Ireland
HRB Clinical Research Facility Galway Recruiting
Galway, Ireland
Contact: Michelle Conboy, Msc       michelle.conboy@nuigalway.ie   
Principal Investigator: Michael Kerin, Prof.         
Sub-Investigator: Brian Moloney, Dr.         
Sponsors and Collaborators
MVG Industries SAS
HRB Clinical Research Facility, Galway (CRFG)
Investigators
Principal Investigator: Michael Kerin, Prof. Galway University Hospital

Additional Information:
Responsible Party: MVG Industries SAS
ClinicalTrials.gov Identifier: NCT03475992     History of Changes
Other Study ID Numbers: TN.32.1.17.SATF.D
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Breast Cyst
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cysts