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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
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mammography

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

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

First Posted
February 20, 2019
Last Updated
February 26, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
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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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