Breast Cancer
Conditions
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 Microwave Breast Imaging (MWBI) 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.
Interventions
DEVICEWavelia #2
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 Optical Breast Contour Detection (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.
Sponsors
MVG Industries SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All patients will have an MBI scan with Wavelia in addition to standard of care procedures
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Detectability Rate of Malignant and Benign Breast Lesions. | 21 days | Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correct Sizing of Breast Lesions With Wavelia MWBI | 21 days | Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip | 21 days | Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast |
| Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan | 21 days | 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. |
Countries
Ireland
Participant flow
Recruitment details
All female patients with an investigator assessed discrete breast abnormality of size \>1cm and who were called to attend the symptomatic breast unit for assessment as per standard of care protocol were considered for participation in this clinical investigation. If eligibility was confirmed patients were enrolled into the study and were scheduled for an MWBI either before or after standard of care assessments
Participants by arm
| Arm | Count |
|---|---|
| Wavelia MWBI Scan Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | All cysts aspirated before Wavelia scan | 1 |
| Overall Study | Device deficiency | 1 |
| Overall Study | Invalid MWBI scan - various reasons - positioning, breast too large, patient movement | 5 |
| Overall Study | MWBI scan of only 1 breast | 3 |
Baseline characteristics
| Characteristic | Wavelia MWBI Scan |
|---|---|
| Age, Customized Overall Demographics | 44 years |
| Race/Ethnicity, Customized Race/Ethnicity Brazilian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Mauritian - South Asian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Romanian | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White Irish | 59 Participants |
| Region of Enrollment Ireland | 62 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 4 / 73 |
| serious Total, serious adverse events | 0 / 73 |
Outcome results
Primary
Assess the Detectability Rate of Malignant and Benign Breast Lesions.
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
Time frame: 21 days
Population: Female patients who had a dominant discrete lesion in one breast who had a technically validated MWBI scan
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Wavelia MWBI scan | Assess the Detectability Rate of Malignant and Benign Breast Lesions. | 56 Dominant Lesions - Malignant & Benign |
95% CI: [80.45, 95.49]
Secondary
Correct Sizing of Breast Lesions With Wavelia MWBI
Endpoint: Maximal linear size difference (in mm) between the MWBI lesion detection and the maximal size reported in the ultrasound lesion size estimates. This is measured as a continuous variable of difference in mm
Time frame: 21 days
Population: Female patients for whom MWBI lesion size and Ultrasound lesion size data were obtained
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Wavelia MWBI scan | Correct Sizing of Breast Lesions With Wavelia MWBI | -1.6 mm |
Other Pre-specified
Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip
Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast
Time frame: 21 days
Population: Female patients who did not have a biopsy clip in situ at time of MWBI scan
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wavelia MWBI scan | Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip | 15 Participants |
95% CI: [65.66, 96.71]
Other Pre-specified
Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan
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: 21 days
Population: Female patients who consented to participate and had a complete or partial MWBI scan of at least one breast
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Wavelia MWBI scan | Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan | 4 Participants |