Synthetic Aperture Radar Detection of Breast Tumours

NCT02493595 | Completed

• 1 other identifier: M5-1
• Study Type: observational
• Target: 264
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammogram Scheduled

Outcome Measures

Primary Outcomes (1)

• Sensitivity of Radio-Wave imaging in the diagnostic breast care clinic

  The research will seek to measure the added value of a radiowave imaging procedure in a diagnostic breast care clinic in improving accuracy of diagnostic outcomes. In particular it will evaluate the ability of radiowave imaging in the younger patient to demonstrate the presence of lesions in tissue which is dense. As a nonionizing radiation it also has potential to be the bulk imaging method of choice in women under 40 who would only be offered a mammogram where the risk benefit justified it, i.e. with a probability of malignancy.

  Duration of the Study, 6 month interval progress assessment

Secondary Outcomes (1)

• Comparison of radio wave image sensitivity in Dense Tissue BIRADS c and d as compared to X-Ray Mammography

  Study result assessed every 6 months

Study Arms (1)

Cancer

Patients attending One-stop Symptomatic Breast Care clinics with suspicion of a breast lesion in one or both breasts.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female Patients with suspicion of breast lesions attending One-Stop Breast Care diagnostic clinics

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Micrima, Ltd.: lead

Study Sites (1)

North Bristol Trust NHS Breast Care Clinic

Bristol, BS10 5NB, United Kingdom

Location

Study Officials

• Michael H Shere, M.R.C.S

  North Bristol NHS Trust, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: July 9, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: August 1, 2018
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

GB (1)