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

Mammography Clinical Trial

— MICROENHANCE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03857152
• Other study ID #: RD17/91109
• Status: Recruiting
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: February 2, 2021

Study information

• Verified date: February 2019
• Source: The Leeds Teaching Hospitals NHS Trust
• Contact: Nisha Sharma, MBChB; MRCP; FRCR; M
• Phone: 01132063798
• Email: nisha.sharma2[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Calcinosis
• Mammography

Intervention

Diagnostic Test:
• 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).

Locations

Country	Name	City	State
United Kingdom	Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of benign biopsies	Total number of benign biopsies identified whilst undergoing CESM.	3 years