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)
Primary Purpose
Mammography
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Contrast enhanced spectral mammography (CESM)
Sponsored by
About this trial
This is an interventional prevention trial for Mammography
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known allergy to contrast
- Renal impairment
- Unable to provide informed consent
- Having radioactive iodine treatment for hyperthyroidism
Sites / Locations
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patient receiving CESM
Arm Description
Patients will receive CESM in addition to normal standard treatment.
Outcomes
Primary Outcome Measures
Number of benign biopsies
Total number of benign biopsies identified whilst undergoing CESM.
Secondary Outcome Measures
Full Information
NCT ID
NCT03857152
First Posted
February 20, 2019
Last Updated
February 26, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03857152
Brief 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
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
February 2, 2021 (Anticipated)
Study Completion Date
February 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mammography
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient receiving CESM
Arm Type
Other
Arm Description
Patients will receive CESM in addition to normal standard treatment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast enhanced spectral mammography (CESM)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of benign biopsies
Description
Total number of benign biopsies identified whilst undergoing CESM.
Time Frame
3 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Known allergy to contrast
Renal impairment
Unable to provide informed consent
Having radioactive iodine treatment for hyperthyroidism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nisha Sharma, MBChB; MRCP; FRCR; M
Phone
01132063798
Email
nisha.sharma2@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS1 3HE,
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can Contrast Enhanced Spectral Mammography (CESM) Reduce the Number of Benign Biopsies for Calcifications Without Negatively Impacting on Detection/Diagnosis of Clinically Significant Calcifications
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