CompletedNot Applicable

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

Ireland73 participantsStarted 2023-03-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assess the Detectability Rate of Malignant and Benign Breast Lesions.

Timeframe: 21 days

Trial details

NCT IDNCT05757427

SponsorMVG Industries SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-13

Results submitted2025-09-17

View on ClinicalTrials.gov More Breast Cancer trials