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

NCT03475992 | Completed Results

• 1 other identifier: TN.32.1.17.SATF
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cyst

Outcome Measures

Primary Outcomes (1)

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

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

  Through study completion, up to 21 days

Other Outcomes (1)

• 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.

  Duration of study - 19 months

Study Arms (3)

Pre-diagnosed breast cancer

EXPERIMENTAL

Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation

Device: Low-power microwave breast imaging system

Pre-diagnosed breast cyst

EXPERIMENTAL

Low-power microwave breast imaging system. No prior biopsy

Device: Low-power microwave breast imaging system

Pre-diagnosed benign lesion

EXPERIMENTAL

Low-power microwave breast imaging system. Core needle biopsy performed ≥14 days before the microwave breast investigation

Device: Low-power microwave breast imaging system

Interventions

Low-power microwave breast imaging system DEVICE

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

Pre-diagnosed benign lesion; Pre-diagnosed breast cancer; Pre-diagnosed breast cyst

Eligibility Criteria

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

You may qualify if:

• Subjects must be able and willing to give written informed consent and to comply with the requirements of this study protocol
• Subject must have attended the Symptomatic Breast Unit with a palpable breast lump
• Subjects must have had a mammogram in the clinical assessment period (≤ 6 weeks before the microwave breast investigation)
• Subjects must be able to comfortably lie reasonably still in a prone position for up to 15 minutes
• Subjects with bra size larger than 32B and cup size larger or equal to B.
• 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.

You may not qualify if:

• Subjects unable to provide written informed consent
• Subjects who are pregnant or breast-feeding
• Subjects who have had previous surgery to the breast
• Subjects who have previously received chemotherapy or radiotherapy to the breast
• Subjects who have had a breast biopsy less than two weeks prior to imaging
• 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
• Post-biopsy patients whose breast tissue is not healed sufficiently for the imaging procedure, in the opinion of the investigator
• Patients who have had or plan to have a breast cyst aspiration before MBI.
• Subjects with significant co-morbidities which, in the opinion of the investigator, may influence the result of the study
• Subjects with prior or concurrent malignancy
• Subjects under the age of 18 years old
• 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
• 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

Sponsors & Collaborators

• MVG Industries SAS: lead
• HRB Clinical Research Facility Galway: collaborator

Study Sites (1)

HRB Clinical Research Facility Galway

Galway, Ireland

Location

Related Links

• The manufacturer of the trialed investigational medical device and sponsor of the clinical investigation
• The investigational site

MeSH Terms

Conditions

Breast Neoplasms; Breast Cyst

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

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

Results Point of Contact

• Title: Luc Duchesne
• Organization: MVG Industries

luc.duchesne@mvg-world.com

0033169298156

Study Officials

• Michael Kerin, Prof.

  Galway University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Model Details: 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).

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 23, 2018
• Study Start: October 10, 2018
• Primary Completion: May 7, 2020
• Study Completion: May 7, 2020
• Last Updated: June 7, 2021
• Results First Posted: June 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)