18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assess the Detectability Rate of Malignant and Benign Breast Lesions.Primary· 21 days
Endpoint: Percentage of malignant and benign breast lesions correctly detected with Wavelia MWBI
Group
Value
95% CI
Wavelia MWBI scan
56
Correct Sizing of Breast Lesions With Wavelia MWBISecondary· 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
Group
Value
95% CI
Wavelia MWBI scan
-1.6
-67.7 – 21.6
Evaluate the Wavelia MWBI Breast Lesion Detectability Rate on Patients With no Biopsy ClipSecondary· 21 days
Endpoint: Percentage of breast lesions correctly detected with Wavelia MWBI on patients with no biopsy clip marking in their breast
Group
Value
95% CI
Wavelia MWBI scan
15
Safety Objective: Provide Further Data to Support the Establishment of the Safety Profile of MWBI ScanSecondary· 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.
Group
Value
95% CI
Wavelia MWBI scan
4
Adverse events — posted to ClinicalTrials.gov
Time frame: 21 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Wavelia MWBI scan
Serious: 0/73 (0%)
Deaths: 0/73
Other adverse events (3 terms — click to expand)
Reaction
System
Wavelia MWBI scan
General disorders and administration site conditions
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
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Other MVG Industries SAS trials
Trials by the same sponsor.
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· NA
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MVG Industries SAS
Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05757427.