Synthetic Aperture Radar Detection of Breast Tumours
Condition: Mammogram Scheduled
Study type: Observational

Summary: 
      The study will seek to understand the effective use of a novel Microwave Radar Breast Imaging
      System in a Symptomatic Breast Care Clinic. The MARIA Imaging system uses low level
      non--ionising radiation (radio wave) signals to scan the breast tissue volume and to provide
      a visual image of areas of varying tissue permittivity value within the volume. These areas
      of varying permittivity can be shown as a two or three dimensional image and used in
      conjunction with the X-Ray mammogram and ultrasound scans to provide another level of
      diagnosis to the radiologist.The system works equally well in both dense and lucent breast
      types and can in particular provide insight into the diagnosis in dense tissue cases. The
      trial will accept symptomatic cases with suspected cancer, cysts or fibroadenoma.

      The trial will use the images produced by the MARIA system and compare them to the images
      obtained using X-Ray mammography. The results of the comparison will be assessed to
      understand the effectiveness of the MARIA image in assisting with the identification and
      location of suspected lesions for further specific analysis using Ultrasound/Biopsy.
    

Detailed description: 
      A potential participant will be asked by the breast care clinician if she would be interested
      in participating in a new form of breast scanning trial; if agrees to consider is given an
      patient information sheet and a brief explanation. After the initial consultation and either
      whilst waiting for, or just after the mammogram, will be approached by the researcher (who is
      a healthcare professional) to ask if she would like to take part.

      Equipment is shown and procedure explained, and if in agreement will be required to sign four
      copies of the consent form. The patient will be asked to remove top clothing and lie prone on
      a specifically designed couch that allows one breast to sit in a ceramic cup containing a
      small amount of contact liquid. The cup position is adjusted to get best fit which is tested
      with short trial scans taking a few seconds each. Once satisfactory the subject is asked to
      keep as still as possible for a 25 second scan. The radiowave array is rotated a few degrees
      and the scan repeated up to four times.

      The scanning procedure takes about 3 to 5 minutes in total, but with questions, consent,
      explanation and dressing the total visit time is about 20 to 25 minutes. The patient is
      returned to the breast care clinic to continue with investigation and management. Personal
      details collected at the time are the subject's age, menopausal status and breast (bra) size.
      Details retrieved from the hospital record system later are the fully anonymised mammogram,
      ultrasound scan and cytology/histology reports if available. No other intervention is needed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female Patients with suspicion of breast lesions attending One-Stop Breast Care diagnostic
        clinics