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

NCT03857152 | Unknown

• 1 other identifier: RD17/91109
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammography

Outcome Measures

Primary Outcomes (1)

• Number of benign biopsies

  Total number of benign biopsies identified whilst undergoing CESM.

  3 years

Study Arms (1)

Patient receiving CESM

OTHER

Patients will receive CESM in addition to normal standard treatment.

Diagnostic Test: Contrast enhanced spectral mammography (CESM)

Interventions

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).

Patient receiving CESM

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy to contrast
• Renal impairment
• Unable to provide informed consent
• Having radioactive iodine treatment for hyperthyroidism

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

Leeds Teaching Hospitals NHS Trust

Leeds, LS1 3HE,, United Kingdom

RECRUITING

Central Study Contacts

Nisha Sharma, MBChB; MRCP; FRCR; M

CONTACT

01132063798; nisha.sharma2@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2019
• First Posted: February 27, 2019
• Study Start: December 3, 2018
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)