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

The Leeds Teaching Hospitals NHS Trust

Status: Unknown

Conditions: Mammography

Treatments: Diagnostic Test: Contrast enhanced spectral mammography (CESM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03857152

RD17/91109

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Patient receiving CESM

Other group

Description:

Patients will receive CESM in addition to normal standard treatment.

Treatment:

Diagnostic Test: Contrast enhanced spectral mammography (CESM)