Pilot Clinical Evaluation of a Microwave Imaging System for Breast Cancer Detection
Breast Cancer
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
Experimental
All patients will have an MBI scan with Wavelia #2 in addition to standard reference imaging.
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.