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Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications

Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03857152
Acronym
MICROENHANCE
Enrollment
250
Registered
2019-02-27
Start date
2018-12-03
Completion date
2021-02-02
Last updated
2019-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mammography

Brief 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. 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.

Interventions

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).

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Recalled for second stage screening due to microcalcifications on the mammogram 2. Renal function is within normal limits 3. No known allergies to contrast 4. Able to give informed consent

Exclusion criteria

1. Known allergy to contrast 2. Renal impairment 3. Unable to provide informed consent 4. Having radioactive iodine treatment for hyperthyroidism

Design outcomes

Primary

MeasureTime frameDescription
Number of benign biopsies3 yearsTotal number of benign biopsies identified whilst undergoing CESM.

Countries

United Kingdom

Contacts

Primary ContactNisha Sharma, MBChB; MRCP; FRCR; M
nisha.sharma2@nhs.net01132063798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026