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

Not Applicable

• Conditions: Mammography
• Interventions: Diagnostic Test: Contrast enhanced spectral mammography (CESM)

• Registration Number: NCT03857152
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-03
• Status Verified: 2019-02
• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-26
• Last Update Submitted: 2019-02-26
• Study First Posted: 2019-02-27
• Last Update Posted: 2019-02-27
• Primary Completion: 2021-02-02
• Study Completion: 2021-02-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient receiving CESM	Contrast enhanced spectral mammography (CESM)	Patients will receive CESM in addition to normal standard treatment.

Primary Outcome Measures

Name	Time	Method
Number of benign biopsies	3 years	Total number of benign biopsies identified whilst undergoing CESM.

Trial Locations

Locations (1)

Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom