Mammogram Scheduled Clinical Trial
Official title:
Post-CE Marking Continuing Evaluation of Multi-Static Microwave Imaging of the Female Breast in Controlled Trial to Identify Optimum Use of the MARIA Platform in the Clinical Workflow
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.
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 trialÍž 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Withdrawn |
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