Mammogram ScheduledMARIANCT02493595
Synthetic Aperture Radar Detection of Breast Tumours
An observational study of Mammogram Scheduled, run by Micrima, Ltd. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Mammogram Scheduled
- How many people
- 264 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female Patients with suspicion of breast lesions attending One-Stop Breast Care diagnostic clinics
Who may be able to join
- 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
Who cannot join
- Breast implants
- Recent Biopsy
- Extremely small or extremely large breasts
- Presence of metal or blood lesion (haematoma)
- Breathlessness or severe arthritis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Bristol Trust NHS Breast Care Clinic
Bristol, BS10 5NB
About this study
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.
Read the 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.
- Conditions
- Mammogram Scheduled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cancer | Patients attending One-stop Symptomatic Breast Care clinics with suspicion of a breast lesion in one or both breasts. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
MARIA image sensitivity will be assessed separately for patients with Higher density breast tissue
Measured: Study result assessed every 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammogram ScheduledStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Micrima, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Shere, M.R.C.S, Principal investigator, North Bristol NHS Trust, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493595
- Sponsor's protocol ID
- M5-1
- Acronym
- MARIA
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02493595
- Acronym / sponsor ID
- MARIA / M5-1
- Conditions
- Mammogram Scheduled
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Micrima, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 9 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer | – | –Patients attending One-stop Symptomatic Breast Care clinics with suspicion of a breast lesion in one or both breasts. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female Patients with suspicion of breast lesions attending One-Stop Breast Care diagnostic clinics
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Breast implants
- Recent Biopsy
- Extremely small or extremely large breasts
- Presence of metal or blood lesion (haematoma)
- Breathlessness or severe arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of Radio-Wave imaging in the diagnostic breast care clinic
Time frame: Duration of the Study, 6 month interval progress assessment
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.
1 secondary outcome
Comparison of radio wave image sensitivity in Dense Tissue BIRADS c and d as compared to X-Ray Mammography
Time frame: Study result assessed every 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Shere, M.R.C.S principal investigator
North Bristol NHS Trust, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammogram Scheduled, run by Micrima, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of Radio-Wave imaging in the diagnostic breast care clinic (time frame: Duration of the Study, 6 month interval progress assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.