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

NCT ID: NCT03857152

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-03
• Study Completion Date: 2021-02-02

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient receiving CESM

Patients will receive CESM in addition to normal standard treatment.

Group Type: OTHER

Contrast enhanced spectral mammography (CESM)

Intervention Type: 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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Nisha Sharma, MBChB; MRCP; FRCR; M

Role: CONTACT

nisha.sharma2@nhs.net

01132063798

Other Identifiers

RD17/91109

Identifier Type: -

Identifier Source: org_study_id