Clinical trial NCT02493595: Synthetic Aperture Radar Detection of Breast Tumours
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mammogram Scheduled
Lead sponsor: Micrima, Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-09
Enrollment: 264
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Referred for diagnosis because of a reported symptom of breast disease
* No previous treatment or biopsy
* Breast size 32A to breast size 42DD
* Able to lie prone on a couch for 10 minutes
* Able to remain reasonably still for 2 minutes

Exclusion Criteria:

* Breast implants
* Recent Biopsy
* Extremely small or extremely large breasts
* Presence of metal or blood lesion (haematoma)
* Breathlessness or severe arthritis

Primary outcomes:
measure: Sensitivity of Radio-Wave imaging in the diagnostic breast care clinic
timeFrame: Duration of the Study, 6 month interval progress assessment
Secondary outcomes:
measure: Comparison of radio wave image sensitivity in Dense Tissue BIRADS c and d as compared to X-Ray Mammography
timeFrame: Study result assessed every 6 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: North Bristol Trust NHS Breast Care Clinic
Study officials:
affiliation: North Bristol NHS Trust, United Kingdom
name: Michael H Shere, M.R.C.S
role: PRINCIPAL_INVESTIGATOR
References: