Back to resultsPilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Wavelia #2
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria: Informed Consent Female subjects with an investigator assessed discrete breast abnormality of size > 1cm Able and willing to comply with the requirements of this study protocol Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential) intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast) Able to comfortably lie reasonably still in a prone position for approximately 15 minutes Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable) Exclusion Criteria: Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator Are pregnant or breast-feeding Have had surgery on either breast within the past 12 months Have any active or metallic implant other than a biopsy clip Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
Sites / Locations
- Galway University Hospital/Symptomatic Breast UnitRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.
Arm Description
Patients with an investigator assessed discrete breast abnormality of size >1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation.
Outcomes
Primary Outcome Measures
Assess the detectability rate of malignant and benign breast lesions.
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MBI
Assess the potential for differentiation between malignant and benign breast lesions, using Wavelia MBI.
Endpoint: Proportion of benign and malignant breast lesions correctly classified with Wavelia MBI
Secondary Outcome Measures
Assess lesion sizing for patients who have undergone surgery post MBI scan and for whom post-surgery histology data is available.
Endpoint: Maximal linear size difference (in mm) between the MBI lesion detection and the maximal size being reported in the post-surgery histological analysis of the excised tumour.
Assess the potential for differentiation between ILC and IDC cancer types, or other cancer types (if sufficient data is available) using Wavelia MBI.
Endpoint: Percentage of cancers correctly classified per cancer type with Wavelia MBI (e.g. ILC, IDC, other).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05757427
Brief Title
Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
Official Title
Open-label,Single Site,Pilot Clinical Investigation to Assess Detectability and Sizing of Invasive Breast Cancers,Detectability of Benign Breast Lesions,Differentiation Between Malignant and Benign Breast Lesions Using Wavelia # 2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MVG Industries SAS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 breast cancer. The physical basis of microwave imaging is the dielectric contrast between healthy and cancerous breast tissues at the microwave frequency spectrum.
This study is a pilot Clinical Evaluation of a microwave imaging system (Wavelia #2) for Breast Cancer Detection. The clinical data that will be collected in the context of this study is intended for the assessment of the imaging diagnostic capability and the safety of the investigational device.
Detailed Description
This study aims to enrol approximately 103 subjects presenting to the symptomatic breast unit with a breast abnormality who consent to undergo an MBI scan using the Wavelia #2 imaging system. The study uses an adaptive design to verify and validate the technical evolutions that have been integrated in the Wavelia# 2 prototype on a small patient dataset (30 patients). Once the technical performance has been established recruitment will continue to assess the clinical performance of the MBI system compared to standard of care reference imaging. The primary objectives of the study are to assess the performance of Wavelia # 2 in the detection of malignant and benign breast lesions, the sizing of malignant lesions for which post-surgery histology data will be available and the differentiation between benign and malignant breast abnormalities by means of features extracted from the MBI images.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will have an MBI scan with Wavelia in addition to standard of care procedures
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.
Arm Type
Experimental
Arm Description
Patients with an investigator assessed discrete breast abnormality of size >1cm and who attend the symptomatic breast unit for assessment as per standard of care protocol will be considered for participation in this clinical investigation.
Intervention Type
Device
Intervention Name(s)
Wavelia #2
Intervention Description
Patients who are eligible and consent to have an MBI breast scan procedure will be asked to confirm their willingness to participate on the day of the breast scan. The patient will first have an OBCD scan, to reconstruct the external surface of the breast with high-precision, measure the total volume and the vertical extent of the breast before the MBI scan. The MBI scan will be performed on both breasts. The process will include optimization of breast positioning and breast cleaning to remove any transition liquid remaining on the skin.
Primary Outcome Measure Information:
Title
Assess the detectability rate of malignant and benign breast lesions.
Description
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MBI
Time Frame
Duration of study - 19 months
Title
Assess the potential for differentiation between malignant and benign breast lesions, using Wavelia MBI.
Description
Endpoint: Proportion of benign and malignant breast lesions correctly classified with Wavelia MBI
Time Frame
Duration of study - 19 months
Secondary Outcome Measure Information:
Title
Assess lesion sizing for patients who have undergone surgery post MBI scan and for whom post-surgery histology data is available.
Description
Endpoint: Maximal linear size difference (in mm) between the MBI lesion detection and the maximal size being reported in the post-surgery histological analysis of the excised tumour.
Time Frame
Duration of study - 19 months
Title
Assess the potential for differentiation between ILC and IDC cancer types, or other cancer types (if sufficient data is available) using Wavelia MBI.
Description
Endpoint: Percentage of cancers correctly classified per cancer type with Wavelia MBI (e.g. ILC, IDC, other).
Time Frame
Duration of study - 19 months
Other Pre-specified Outcome Measures:
Title
Evaluate the Wavelia MBI breast lesion detectability rate (either malignant or benign) on patients with no biopsy clip, marking the lesion position in the breast.
Description
Endpoint: Percentage of malignant and the percentage of benign breast lesions correctly detected with Wavelia MBI on pre-biopsy patients, with no biopsy clip in their breast will be represented by a binary variable which will be assigned the value of 1 if the lesion benign or malignant was detected by the device and 0 (zero) otherwise.
Time Frame
Duration of study - 19 months
Title
Safety objective: provide further data to support the establishment of the safety profile of the investigational medical imaging device and associated procedures
Description
Endpoint: Incidence of Serious Adverse Events and Serious Adverse Device Effects during the total duration of the trial as well as other adverse events reported.
Time Frame
Duration of study - 19 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Informed Consent
Female subjects with an investigator assessed discrete breast abnormality of size > 1cm
Able and willing to comply with the requirements of this study protocol
Negative urine pregnancy test on the day of microwave imaging procedure (if of childbearing potential)
intact breast skin (i.e., without bleeding lesion, no evidence of inflammation and/or erythema of the breast)
Able to comfortably lie reasonably still in a prone position for approximately 15 minutes
Have had biopsy more than 2 weeks prior to the microwave breast investigation (if applicable)
Exclusion Criteria:
Have a cup size of A or whose breast is deemed too small to allow MBI assessment in the opinion of the investigator
Are pregnant or breast-feeding
Have had surgery on either breast within the past 12 months
Have any active or metallic implant other than a biopsy clip
Would be unsuitable for an MBI scan or unlikely to follow the protocol in the opinion of the Investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luc Duchesne
Phone
+33 (0)1 69 29 81 56
Email
luc.duchesne@mvg-world.com
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Fasoula, PhD
Phone
+33 (0)1 69 29 02 47
Email
angie.fasoula@mvg-world.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kerin
Organizational Affiliation
Galway University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Galway University Hospital/Symptomatic Breast Unit
City
Galway
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kerin, Prof.
Phone
+353 91 524222
Email
michael.kerin@universityofgalway.ie
First Name & Middle Initial & Last Name & Degree
Michael Kerin
12. IPD Sharing Statement
Plan to Share IPD
No
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Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
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