Table 1.

Inclusion and exclusion criteria set out for the study

Inclusion criteria

1. Symptomatic presentation with a palpable breast lump.

2. Mammography performed at time of presentation (<6 weeks prior to MBI)

3. Capable of comfortably lying in a prone position for 15 min.

4. Subjects with bra size larger than 32B and cup size larger or equal to B.

5. Subjects whose submerged breast would allow a sufficient margin to accommodate the transition liquid around the breast within the cylindrical container. Satisfaction of criteria determined by the clinician at time of initial clinical assessment.

Exclusion criteria

1. Pregnant or breast-feeding.

2. Previous surgery to the breast.

3. Previously received chemotherapy or radiotherapy to the breast.

4. Subjects who have had a breast biopsy within the previous two weeks.

5. Subjects with any active or metallic implant or bearing any nonremovable object.

6. Post-biopsy patients whose breast tissue is not healed sufficiently.

7. Breast cyst aspiration before MBI.

8. Significant co-morbidities.

9. Prior or concurrent malignancy.

10.Under the age of 18 years old.

11.Inflammation and/or erythema of the breast and/or break in the skin.

MBI, Microwave Breast Imaging.