MammographyMICROENHANCENCT03857152
Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
A study testing Contrast enhanced spectral mammography (CESM) in people with Mammography, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Mammography
- What is being tested?
- Contrast enhanced spectral mammography (CESM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Dec 2018to 2 Feb 2021
- Phase
- Interventional
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recalled for second stage screening due to microcalcifications on the mammogram
- Renal function is within normal limits
- No known allergies to contrast
- Able to give informed consent
Who cannot join
- Known allergy to contrast
- Renal impairment
- Unable to provide informed consent
- Having radioactive iodine treatment for hyperthyroidism
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Teaching Hospitals NHS Trust
Leeds, LS1 3HE,
About this study
Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.
- Conditions
- Mammography
- Being tested
- Contrast enhanced spectral mammography (CESM)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast enhanced spectral mammography (CESM)Diagnostic test
Contrast enhanced spectral mammography (CESM) will be undertaken in addition to routine practice.
CESM is a specialist mammography test that aims to 'highlight' areas of concern within the breast in more detail than a standard mammogram.
The difference between CESM and a standard mammogram (x-ray of the breast) is the use of a special dye (called contrast medium) that is injected into the veins before the mammogram images are taken. The contrast enhanced images give more detailed information to the breast radiologists (expert doctors trained to analyse breast imaging).
| Study group | Role | What they receive |
|---|---|---|
| Patient receiving CESM | Other | Patients will receive CESM in addition to normal standard treatment. Receives: Diagnostic Test: Contrast enhanced spectral mammography (CESM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of benign biopsies
Total number of benign biopsies identified whilst undergoing CESM.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start3 Dec 2018
- Primary completion2 Feb 2021 (estimated)
- Study completion2 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MammographyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857152
- Sponsor's protocol ID
- RD17/91109
- Acronym
- MICROENHANCE
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
- ClinicalTrials.gov ID
- NCT03857152
- Acronym / sponsor ID
- MICROENHANCE / RD17/91109
- Conditions
- Mammography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 2 Feb 2021 (estimated)
- Study completion
- 2 Feb 2021 (estimated)
- First posted
- 27 Feb 2019 (actual)
- 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.
Women who attend for their screening mammogram will be recalled if an abnormality is detected on the screening mammogram. Calcifications account for 20% of the women recalled to second stage screening. Currently there is no effective imaging tool to determine if the calcifications are cancer or not. Therefore, 90% of women will be subjected to a biopsy. 25-30% of the biopsies will show cancer. Contrast enhanced spectral mammography (CESM) is where contrast is given and then a mammogram performed. The theory is that high risk DCIS and invasive cancers have an increased blood supply and will therefore enhance more than benign lesions within the breast. If CESM can identify calcifications that are cancerous then we maybe able to reduce the number of women who have benign biopsies. This is patient focused as women would not require a biopsy and be able to be reassured at the same visit. This is also a cost-saving for the Trust by reducing unnecessary biopsies. This also supports the findings of the Marmot review by aiming to reduce harm by over-diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient receiving CESM | Other | Diagnostic Test: Contrast enhanced spectral mammography (CESM)Patients will receive CESM in addition to normal standard treatment. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recalled for second stage screening due to microcalcifications on the mammogram
- Renal function is within normal limits
- No known allergies to contrast
- Able to give informed consent
Key exclusion criteria (4 listed)
- Known allergy to contrast
- Renal impairment
- Unable to provide informed consent
- Having radioactive iodine treatment for hyperthyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast enhanced spectral mammography (CESM)Contrast enhanced spectral mammography (CESM) will be undertaken in addition to routine practice. CESM is a specialist mammography test that aims to 'highlight' areas of concern within the breast in more detail than a standard mammogram. The difference between CESM and a standard mammogram (x-ray of the breast) is the use of a special dye (called contrast medium) that is injected into the veins before the mammogram images are taken. The contrast enhanced images give more detailed information to the breast radiologists (expert doctors trained to analyse breast imaging). | Diagnostic test | Patient receiving CESM |
Primary outcome
Number of benign biopsies
Time frame: 3 years
Total number of benign biopsies identified whilst undergoing CESM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast enhanced spectral mammography (CESM) in people with Mammography, run by The Leeds Teaching Hospitals NHS Trust 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nisha Sharma, MBChB; MRCP; FRCR; M (01132063798, nisha.sharma2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of benign biopsies (time frame: 3 years). 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 27 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.