Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-25 @ 5:11 AM
NCT ID:
NCT05757427
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05757427
Study Brief:
Protocol Section:
NCT05757427