Trial Outcomes & Findings for Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection (NCT NCT05757427)

Results Overview

Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

73 participants

Primary outcome timeframe

21 days

Results posted on

2025-11-26

Participant Flow

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

Participant milestones

Participant milestones
Measure	Wavelia MWBI scan Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Overall Study STARTED	73
Overall Study COMPLETED	62
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Wavelia MWBI scan Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Overall Study Adverse Event	1
Overall Study Device deficiency	1
Overall Study All cysts aspirated before Wavelia scan	1
Overall Study MWBI scan of only 1 breast	3
Overall Study Invalid MWBI scan - various reasons - positioning, breast too large, patient movement	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wavelia MWBI Scan n=62 Participants Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Age, Customized Overall Demographics	44 years n=492 Participants
Sex: Female, Male Female	62 Participants n=492 Participants
Sex: Female, Male Male	0 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · White Irish	59 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Brazilian	1 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Mauritian - South Asian	1 Participants n=492 Participants
Race/Ethnicity, Customized Race/Ethnicity · Romanian	1 Participants n=492 Participants
Region of Enrollment Ireland	62 participants n=492 Participants

PRIMARY outcome

Timeframe: 21 days

Population: Female patients who had a dominant discrete lesion in one breast who had a technically validated MWBI scan

Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI

Outcome measures

Outcome measures
Measure	Wavelia MWBI scan n=62 Dominant Lesions - Malignant & Benign Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Assess the Detectability Rate of Malignant and Benign Breast Lesions.	56 Dominant Lesions - Malignant & Benign

SECONDARY outcome

Timeframe: 21 days

Population: Female patients for whom MWBI lesion size and Ultrasound lesion size data were obtained

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

Outcome measures

Outcome measures
Measure	Wavelia MWBI scan n=57 All Lesions - Malignant & Benign Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Correct Sizing of Breast Lesions With Wavelia MWBI	-1.6 mm Interval -67.7 to 21.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 21 days

Population: Female patients who did not have a biopsy clip in situ at time of MWBI scan

Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast

Outcome measures

Outcome measures
Measure	Wavelia MWBI scan n=17 Participants Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy Clip	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 21 days

Population: Female patients who consented to participate and had a complete or partial MWBI scan of at least one breast

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.

Outcome measures

Outcome measures
Measure	Wavelia MWBI scan n=73 Participants Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI Scan	4 Participants

Adverse Events

Wavelia MWBI scan

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Wavelia MWBI scan n=73 participants at risk Female patients who met all inclusion and exclusion criteria and completed an MWBI on both breasts with the technically validated MWBI
Immune system disorders Immune system disorders	1.4% 1/73 • Number of events 1 • 21 days Adverse Events and Adverse Device Effects were recorded from patient consent until the End of Study Follow Up Visit (up to 21 days post MWBI or prior to surgery, whichever happened first). Comprehensive assessments of any adverse event/device experienced by the subject was performed throughout the course of the study. Adverse events which occurred in Users or Other Persons (not study subjects) were also collected throughout the study along with device deficiencies
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.4% 1/73 • Number of events 1 • 21 days Adverse Events and Adverse Device Effects were recorded from patient consent until the End of Study Follow Up Visit (up to 21 days post MWBI or prior to surgery, whichever happened first). Comprehensive assessments of any adverse event/device experienced by the subject was performed throughout the course of the study. Adverse events which occurred in Users or Other Persons (not study subjects) were also collected throughout the study along with device deficiencies
General disorders General disorders and administration site conditions	2.7% 2/73 • Number of events 2 • 21 days Adverse Events and Adverse Device Effects were recorded from patient consent until the End of Study Follow Up Visit (up to 21 days post MWBI or prior to surgery, whichever happened first). Comprehensive assessments of any adverse event/device experienced by the subject was performed throughout the course of the study. Adverse events which occurred in Users or Other Persons (not study subjects) were also collected throughout the study along with device deficiencies

Additional Information

Luc Duchesne

MVG Industries SAS

Phone: +33 (0) 6 70 33 91 20

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60